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

OP RSH PRO00039797 SUN MK-1022 SURGERY PHASE	

Types:      Research Oncology Treatment
Synonyms:  

Pre-Surgery Safety Visit	Repeat 1 time	Cycle length: 1 day	30 days after last dose of neoadjuvant treatment	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing  Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   MK1022-010_Sun
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Patritumab Deruxtecan Treatment: Refer to Section[AR1]  6.6.1
Protocol Access Hyperlink:   MK1022-010_Sun
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Additional clinical procedures/assessments may be performed at any time, as clinically indicated
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	If surgery is scheduled to occur <30 days after the last dose of the neoadjuvant treatment, the Pre-surgery Safety Visit should occur before surgery.
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	An EOT/Discontinuation Visit should be conducted for participants who do not undergo on-study definitive surgery or who discontinue study intervention at any other point during the Surgery Phase. If the reason definitive surgery on-study is not performed or study intervention is discontinued during the Surgery Phase is distant recurrence/progression, participants in Part 2 should then enter Survival Follow-up. If definitive surgery on-study is not performed or study intervention is discontinued during the Surgery Phase for any other reason, participants in Part 2 should enter Efficacy Follow-up after the EOT/Discontinuation Visit [Table 5]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	A participant is not required to receive a minimum number of neoadjuvant treatment cycles before undergoing on-study definitive surgery. Sponsor consultation and completion of SCF is required if participant completes fewer than 12 weeks of neoadjuvant treatment before undergoing definitive surgery.
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	For participants in Part 2, Post-surgery Safety Visit can be combined with Adjuvant C9D1 Visit [Table 4] if C9 begins at 30 (±3) days after surgery. If a participant discontinues study intervention after definitive surgery on-study but before the Post-surgery Safety Visit, then only one visit is performed under the EOT/Discontinuation Visit. All activities for both the Post-surgery Safety Visit and the EOT/Discontinuation Visit are to be completed on that visit [Table 5].
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	For participants who require >1 surgical procedure to complete definitive surgery, the Post-surgery Safety Visit is to be completed 30 (±3) days after the last surgical procedure.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	For participants in Part 1, Post-surgery Safety Visit will serve as both EOT and Safety Follow-up Visit. All activities for the Post-surgery Safety Visit, the EOT/Discontinuation Visit, and the Safety Follow-up Visit are to be completed on that visit [Table 5].
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, EORTC QLQ-BR42, FACIT Item GP5

Complete before performing any other procedures/assessments on the day of visit.
Administer EORTC QLQ-BR42 to female participants only.
			Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Concomitant medication Review.
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Vital Status Continuously 

On Sponsor request, all participants may be contacted for survival information at any time during the study
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	AE/SAE Review Continuously
			Imaging
◉	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Should be obtained after C8D1 but before definitive surgery for participants who consent to optional MRI exams.
Note: the optional MRI will not be performed during the Part 1 (Safety Lead-in).
		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Should be obtained after C8D1 but before definitive surgery for participants who consent to optional MRI exams.
Note: the optional MRI will not be performed during the Part 1 (Safety Lead-in).
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	Assessment for Disease

Assess for disease progression/recurrence and any evidence of second primary malignancy, as clinically appropriate, based on physical exam, imaging, and/or tissue.
Other than for participants who consent to optional Breast MRI exams, imaging to assess disease status is not mandated and should be performed as clinically indicated, per standard of care. 
Any imaging performed to assess disease status as part of SOC will be collected and held centrally.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Full Physical Examination
			Ophthalmology
  	ONC NURSING COMMUNICATION 38	Interval: --	Occurrences: --	Comments:	Ophthalmologic Assessments - Required for Arms A and B, and perform as clinically indicated for Arm C.
Includes a visual acuity test (ETDRS, Snellen or Landolt), slit lamp examination, fundoscopy, and tonometry.
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	Echo or MUGA
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	Echo or MUGA
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include BP, pulse rate, RR, temperature, and SpO2.
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Urine or Serum Pregnancy Test. (POCBP only).
		◯	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Urine or Serum Pregnancy Test. (POCBP only)
		◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or Serum Pregnancy Test. (POCBP only)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	CORTISOL LEVEL, AM	Interval: --	Occurrences: --	Comments:	Must be collected in the morning within 14 days before surgery. Results should be available and reviewed before surgery. Surgery should be delayed at investigator's discretion if there are concerns about adrenal insufficiency.
			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	PRE-Surg and as clinically indicated for participants taking anticoagulant therapy
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	PRE-Surg and as clinically indicated for participants taking anticoagulant therapy
			Labs
  	TROPONIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	B NATRIURETIC PEPTIDE	Interval: --	Occurrences: --	Comments:	As clinically indicated
					
Definitive Surgery (DS)	Repeat 1 time	Cycle length: 1 day	Within 3 to 6 weeks after last dose of the Neoadjuvant treatment, as clinically appropriate	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Pathologic Assessment of specimen from surgical resection

pCR and RCB assessments will be performed by local pathologist.
			Nursing Orders
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Tumor Tissue from Surgical Resection for Biomarker Research.

Collect, if possible, from participants who do not achieve pCR and who have sufficient tumor volume, as assessed by local pathologist.
					
Post-surgery Safety Visit (POST-Surg )	Repeat 1 time	Cycle length: 1 day	30 days after Definitive surgery	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Concomitant medication Review.
			Nursing Orders
  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Vital Status Continuously 

On Sponsor request, all participants may be contacted for survival information at any time during the study
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	AE/SAE Review Continuously
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Full Physical Examination
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	ECOG
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include BP, pulse rate, RR, temperature, and SpO2.
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --