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OP RESEARCH PRO00037808 D361DC00001 SUN ARM A	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Perform Pre and 1-2h post on C1D1
		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o On C1D1 pre and 1-2h post. 
o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Prepare ePRO device: The handheld device should be charged and set up for the participant prior to their arrival at the site for their baseline PRO assessments, in accordance with device training.
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Train participant on ePRO device: The participant should be trained on the use of the device and the importance of completing the PRO questionnaires in accordance with the schedule throughout the study.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Randomization: Randomization must occur within 28 days of the start of screening. Every effort should be made to minimize the time between randomization and starting treatment (ie, within 3 business days of randomization). Ideally, randomization and Cycle 1, Week 1, Day 1 should occur on the same day.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Laboratory safety assessment samples must be collected pre-dosing. PK sampling (pre-dose and post-dose time points) must be collected on a study day where capivasertib is administered
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	The sample for genetic research will be obtained at Day 1 pre-dose. If, for any reason, the sample is not drawn at Day 1, it may be taken at any visit until the last study visit. Only 1 sample should be collected per participant for genetics during the study.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For pre- and perimenopausal ONLY.
			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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						Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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						Day 18	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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						Day 15	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 14	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 21	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Cycle 22	Repeat 1 time	Cycle length: 35 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	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 Protocol Access hyperlink:    D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Capivasertib Treatment : Refer to TABLE 15-16-17-18 Pg 136 to 145.Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Palbociclib Treatment : Refer to Table 12 Pg134 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Ribociclib Treatment  : Refer to Table 13 Pg 135 Protocol Access Hyperlink:   D361DC00001 CAP1292 PH 3_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	Please ensure patient takes prescribed oral medications provided by IDS pharmacy.

Arm A: 
Capivasertib - C1 to EOT / day 1 to 4 of each week. (twice daily 4 days on 3 days off/week for 4 weeks).
Palbociclib - C1 to EOT/D1 (21 days of 28-day cycle).
Ribociclib - C1 to EOT/D1 to D28 (21 days of 28-day cycle).
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must becollected pre-dosing.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ESTRADIOL LEVEL	Interval: --	Occurrences: --		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --			Chemotherapy
  	INV-Fulvestrant (CAPItello-292/Pro00037808/Sun) INTRAMUSCULAR injection 500 mg	Dose: 500 mg	Route: intramuscular	once over 1-2 Minutes for 1 dose	Start: S			Instructions:	Box contains 2 open label Fulvestrant 250mg/5mL prefilled syringes. Keep refrigerated away from children. Inject 250mg/5mL intramuscularly into buttocks slowly over 1-2 minutes; one syringe per buttock. Dispose off used syringes appropriately - follow instructions provided by research staff. 
HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			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.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	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							
Discontinuation	Repeat 1 time	Cycle length: 24 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For pre- and perimenopausal ONLY.
					
FUP	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o All ECGs to be conducted as triplicate measurements, within approximately 5 minutes of starting (the 3 ECGs separated by approximately 2 minutes). Assessments should be performed as close as possible to, but within 30 minutes of the nominal time point
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Survival status: In addition to regular contacts at 8-week intervals, participants will be contacted in the 7 days following a specified date (data cutoff date) for survival analysis
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Subsequent cancer therapy following discontinuation of study treatments
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PFS2: Participants will enter the PFS2 follow-up period once the participant has discontinued study treatment due to progressive disease by RECIST v1.1 per BICR assessment. Progression on second-line treatment will be documented by site personnel at the 30-day follow-up visit, every 8 weeks (±7 days) for the first 2 years and every 12 weeks (±7 days) thereafter until second progression. Survival status and subsequent cancer therapies will be documented by site personnel, following objective disease progression per BICR assessment or treatment discontinuation, at the 30-day follow-up, every 8 weeks (±7 days) for the first 2 years and every 12 weeks (±7 days) thereafter until end of study, study withdrawal or death.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEMOGLOBIN A1C	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	ABSOLUTE NEUTROPHIL COUNT	Interval: --	Occurrences: --		  	ABSOLUTE LYMPHOCYTE COUNT	Interval: --	Occurrences: --	Comments:	!!! Performed ONLY at HMH !!!
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --					
Progression	Repeat 1 time	Cycle length: 56 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	WHO/ECOG performance status
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR45 (females ONLY): Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 32	Interval: --	Occurrences: --	Comments:	EQ-5D-5L: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	PGIS: Cycle 1, Week 1, Day 1 (-3 days) and every 4 weeks (±3 days) until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to the discontinuation or progression visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	PGIC: Every 4 weeks (±3 days) after Cycle 1, Week 1, Day 1 until PFS2. Also, at discontinuation of study treatment visit (+2 days) and, for those who discontinue for reasons other than progression, also at progression visit (+2 days). If PROs have been completed up to 3 days prior to discontinuation or progression visit, they do not need to be repeated.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	From Cycle 2 onwards, if necessary, the collection of blood samples for biomarker analysis (ctDNA sample, circulating soluble factors sample, and whole blood DNA sample and whole blood RNA sample) sampling may be performed 1 business day before the scheduled study visit. These samples must be collected pre-dosing. 
Circulating soluble factor, whole blood DNA sample and whole blood RNA sample draws: To be taken at screening, pre-dose on Cycle 1, Week 1, Day 1;Cycle 1, Week 3, Day 1; Cycle 2, Week 1, Day 1; Cycle 3, Week 1, Day 1, and at discontinuation and/or at progression only.
					
SUP	Repeat 1 time	Cycle length: 56 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Survival status: In addition to regular contacts at 8-week intervals, participants will be contacted in the 7 days following a specified date (data cutoff date) for survival analysis
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Subsequent cancer therapy following discontinuation of study treatments
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Prior/concomitant medication: The use of any natural/herbal products or other "folk remedies" should be discouraged, but use of these products, as well as use of all vitamins, nutritional supplements, and all other concomitant medications must be recorded in the eCRF.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	PGI-TT: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	PRO-CTCAE: Cycle 1, Week 1, Day 1 (-3 days) and every 2 weeks (±2 days) up to and including Week 12 and then every 4 weeks (±3 days) until discontinuation of study treatment, at discontinuation of study treatment visit (+2 days) and at 4 weeks (±3 days) post-discontinuation of study treatment visit. If PROs have been completed up to 3 days prior to discontinuation visit, they do not need to be repeated
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Healthcare resource use (HOSPAD): Resource module to be captured until 30 days after last dose or until progression, whichever occurs later.
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Adverse events
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT chest, abdomen and pelvis from CT (preferred) or MRI: Every 8 weeks (±7 days) for the first 24 months and every 12 weeks (±7 days) thereafter, from randomization to radiological progression by RECIST v1.1 per BICR assessment. Participants who discontinue treatment prior to progression should continue to be scanned until progression per BICR assessment.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PFS2: Participants will enter the PFS2 follow-up period once the participant has discontinued study treatment due to progressive disease by RECIST v1.1 per BICR assessment. Progression on second-line treatment will be documented by site personnel at the 30-day follow-up visit, every 8 weeks (±7 days) for the first 2 years and every 12 weeks (±7 days) thereafter until second progression. Survival status and subsequent cancer therapies will be documented by site personnel, following objective disease progression per BICR assessment or treatment discontinuation, at the 30-day follow-up, every 8 weeks (±7 days) for the first 2 years and every 12 weeks (±7 days) thereafter until end of study, study withdrawal or death.