If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

OP RESEARCH PRO00037866 / DB-1303-O-3002 NIRAVATH ARM 1	

Types:      Research Oncology Treatment
Synonyms:  ARM1

Take Home Medication	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Take-Home Medications
☑	ondansetron ODT (ZOFRAN-ODT) 8 MG disintegrating tablet	Dose: 8 mg	Route: oral	every 8 hours PRN	Dispense: 15 tablet	Refills: 1	Start: S				☑	OLANZapine (ZyPREXA) 5 MG tablet	Dose: 5 mg	Route: oral	nightly	Dispense: 3 tablet	Refills: 5	Start: S			Instructions:	Take 1 tablet by mouth at bedtime on days 2-4 of each cycle		☑	dexAMETHasone (DECADRON) 4 MG tablet	Dose: 8 mg	Route: oral	daily	Dispense: 6 tablet	Refills: 5	Start: S			Instructions:	Take 2 tablets by mouth once daily on day 2-4 of each cycle					
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Randomization:  Every effort should be made to minimize the time between randomization and starting treatment (i.e., no more than 3 days from the date of randomization). 
Every effort should be made to minimize the time between randomization and starting treatment (i.e., no more than 3 days from the date of randomization).
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Patient Reported Outcomes (PROs): Allocate ePRO device 
The electronic PRO device should be charged and fully functional prior to the subject's arrival at the site for Cycle 1 Day 1 (-3 days) to ensure that the PROs can be completed at the start of the visit.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Patient Reported Outcomes (PROs): ePRO subject training 
The subject should be trained on the use of the device, including the importance of completing the PRO questionnaires throughout the study in accordance with the completion schedule.
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Biomarker sampling:  See Table 3 for detailed biomarker sampling schedule.
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
				Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Nursing Orders
  	CT CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	A non-contrast HRCT scan of the chest is preferred if feasible, otherwise a non-contrast CT is acceptable. The HRCT/CT chest scan will be performed for all subjects, in addition to standard CT/MRI scans of chest/abdomen/pelvis for tumor assessments. If both an HRCT/CT of the chest for assessment of ILD/pneumonitis and a diagnostic IV contrast enhanced chest CT scan for tumor response assessment (as part of chest-abdomen-pelvis imaging) are to be acquired in the same imaging session, HRCT/CT should be performed first. HRCT scans are acquired on study as and when ILD/pneumonitis is suspected/as clinically indicated.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Procedures
  	CV ECHOCARDIOGRAM TRANSESOPHAGEAL	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Procedures
  	CV ECHOCARDIOGRAM TRANSESOPHAGEAL	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Procedures
  	CV ECHOCARDIOGRAM TRANSESOPHAGEAL	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Procedures
  	CV ECHOCARDIOGRAM TRANSESOPHAGEAL	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Procedures
  	CV ECHOCARDIOGRAM TRANSESOPHAGEAL	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	The same CT or MRI method of assessment should be used to characterize each identified and reported lesion at baseline, during the study and follow-up. Subjects who discontinue study treatment early for reasons other than disease progression will continue to undergo tumor assessments following the original schedule until the start of new systemic anticancer therapy, disease progression, death, lost to follow-up, or withdrawal of consent, whichever occurs first. Requirements and details for tumor assessments are provided in Section 8.1.1.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
EOT	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR45, EQ-5D-5L, PRO-CTCAE
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	On SCN, C1D1, and D1 of subsequent cycles, SpO2 should be evaluated within 3 days before DB-1303 infusion. If the SpO2 of SCN is performed within 3 days before C1D1 and the subject's condition has not changed, there is no need to repeat the SpO2 of C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	As clinically indicated.  At screening, ECGs will be obtained in triplicate. Subsequent ECGs will be performed in triplicate only if an abnormality is noted. When performed in triplicate, 3 individual ECG tracings should be obtained in succession within 10 minutes after being in a supine/semi-recumbent position for 5 minutes. 12-lead ECG should be performed before infusion on dosing days of every cycle and EOT. Additional assessments may be performed when clinically indicated
			Procedures
  	CV ECHOCARDIOGRAM TRANSESOPHAGEAL	Interval: --	Occurrences: --		  	NM X GATED BLOOD POOL SINGLE (MUGA RESTING)	Interval: --	Occurrences: --			Procedures
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ophthalmologic assessment: include visual acuity testing, and slit lamp examination at the SCN and EOT, and as clinically indicated during treatment.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Biomarker sampling:  See Table 3 for detailed biomarker sampling schedule.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
		  	TROPONIN T	Interval: --	Occurrences: --			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
					
Safety Follow Up	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Targeted physical examination: On Day 1 of each Cycle, targeted physical examination should be evaluated before infusion starting. Additional assessments may be performed when clinically indicated.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG PS for screening visit should be performed within 7 days prior to C1D1, details about the grade refer to Section 8.2.8.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Concomitant medication
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PFS2 =time to second progression or death
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent cancer therapy following EOT
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure will be assessed.
Blood pressure and pulse measurements will be assessed seated position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones).
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
Include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the subject in a quiet setting without distractions.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	Initial infusion dose for each subject will be calculated based on the subject's weight at screening. If the subject's weight has changed by = ± 10%, the subject's dose will be recalculated based on the subject's updated weight.
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine
					
Long-term Follow Up	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  DB-1303-O-3002_Niravath
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse events: collection of all AEs regardless of attribution should begin from the time of signing of the ICF until Safety FU visit. Only ongoing or new AEs related to study drug should be collected during the Long-term FU period. All AE/SAE and AESI that are ongoing at the Safety FU visit, whether related to study treatment, will be followed up in the follow-up period until recovery or return to baseline or become stable assessed by investigator, or death or lost to follow-up.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Survival status
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PFS2 =time to second progression or death
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Subsequent cancer therapy following EOT
			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PK sampling:  See Table 2 for detailed PK sampling schedule
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ADA sampling:  See Table 2 for detailed ADA sampling schedule. PK assay can be performed on the ADA sample collected if a PK sample is not collected at that visit and deemed necessary.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Specific gravity, pH, glucose, blood, protein, ketones, bilirubin, urobilinogen. Sediments: casts, RBCs, WBCs. Protein: If the subject's urine protein is 2+ or above during the study, a 24-hour urine should be collected for a 24-hour urine protein quantitative test.Microscopic examination (if indicated).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For female subjects of childbearing potential, a serum ß-HCG pregnancy test should be performed during the SCN (within 7 days prior to randomization) and at the EOT visit, and a urine/serum pregnancy test should be performed within 3 days prior to infusion of every cycle. If the serum ß-HCG pregnancy test of SCN is performed within 3 days before C1D1, there is no need to repeat the urine pregnancy test of C1D1. Any positive urine pregnancy test result must be confirmed immediately using a serum test.
			Pre-Medications
☑	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy.		☑	OLANZapine (ZYPREXA) tablet 5 mg	Dose: 5 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy		☑	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30 minutes before chemotherapy			Chemotherapy
  	INV-DB-1303 (DYNASTY-Breast02/Pro00037866/Niravath) 8 mg/kg in dextrose 5% 100 mL infusion	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer IV infusion over xx minutes through a 0.2 micron inline filter over 90 minutes for the initial infusion. Subsequent infusions may be given over 60 minutes. 
After the infusion, flush with NS per normal procedure. 
Stable 4 hours at room temp, including infusion (24 hours refrigerated). 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DB-1303 100 MG INTRAVEOUS SOLN (DYNASTY-BREAST02/PRO00037866/NIRAVATH)	Medications	8 mg/kg	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Please confirm that the patient has a script for capecitabine