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 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  MK-1022, PRO00039797, SUN

Screening	Repeat 1 time	Cycle length: 28 days	-28 Days	Perform every 1 day x1			Research tolerance: -0/+0 days	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:	Informed consent. Includes optional Additional Research consent, see Section 8.1.1.3.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent for Optional Breast MRI Exams. Breast MRI exams are optional and will be performed at selected sites in participants who consent to them (Part 2 only).
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Participant ID Card
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Demographics and Medical history
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	After central confirmation of ER, PgR, and HER2 status, indicate if participant has TNBC or HR-low+/HER2- breast cancer. Participants with multifocal/multicentric/bilateral tumors should be classified as TNBC if ALL foci are TNBC, and classified as HR - low+/HER2- if one or more foci are HR low+/HER2-.
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Determine Stratification Factors. Complete prior to initiating IRT (Part 2 only)
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Breast Cancer Diagnosis Details. 
gBRCA status testing not required. If clinically indicated, gBRCA testing is to be performed before initiation of the Adjuvant Treatment Phase per local SOC/guidelines
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Menopausal Status.
Assess in participants who are assigned female sex at birth.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Full physical examination
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Document Intended Adjuvant TPC and Rationale.
Prior to randomization in Part 2 only, the investigator must document the choice of intended optional additional adjuvant TPC should the participant be assigned to Arms A or B and have residual disease. See Section 2.2.8 for additional adjuvant TPC options
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Ophthalmologic assessments
-  Including but not limited to visual acuity testing, slit lamp examination, intraocular pressure measurement, fundoscopy, and fluorescein staining.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Prior/Concomitant Medication Review
		  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Tumor Tissue for Biomarkers.

For central confirmation of histology, ER, PgR, HER2, HER3, and PD-L1 status and biomarker research. If less tissue is available than is requested in the Laboratory Manual, an SCF is required for participant eligibility. Date of biopsy for tissue diagnosis used for eligibility must be within 28 days prior to signing the informed consent, or within 29 to 56 days prior to signing the informed consent with Sponsor consultation and completion of SCF.
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include BP, pulse rate, RR, temperature, and SpO2.
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
◉	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --			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
				Within -14 days	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
◯	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Urine or Serum Pregnancy Test. (POCBP only).

 Negative test required within 24 h (urine test) or 72 h (serum test) before dosing.
		◯	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	Urine or Serum Pregnancy Test. (POCBP only) 
Negative test required within 24 h (urine test) or 72 h (serum test) before dosing.
		◉	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Urine or Serum Pregnancy Test. (POCBP only) 
Negative test required within 24 h (urine test) or 72 h (serum test) before dosing.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			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
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	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.
			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Measure for confirmation of menopausal status, if clinically indicated, in LESS THAN 60-year-old participants assigned female sex at birth.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	Measure for confirmation of menopausal status, if clinically indicated, in LESS THAN 60-year-old participants assigned female sex at birth.
			Labs
  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --	Comments:	Perform only if required per Section 5.1, Section 5.2, and by local health authority.
		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --	Comments:	Perform only if required per Section 5.1, Section 5.2, and by local health authority.
		  	HEPATITIS B CORE ANTIBODY IGM	Interval: --	Occurrences: --	Comments:	Perform only if required per Section 5.1, Section 5.2, and by local health authority.
		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --	Comments:	Perform only if required per Section 5.1, Section 5.2, and by local health authority.
		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --	Comments:	Perform only if required per Section 5.1, Section 5.2, and by local health authority.
			Labs
  	TROPONIN	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	B NATRIURETIC PEPTIDE	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Nursing Orders
  	ONC NURSING COMMUNICATION 62	Interval: --	Occurrences: --	Comments:	If rescreening is needed, the rescreening window starts after the full screening window has elapsed. Rescreening for eligibility requires Sponsor consultation and completion of SCF.
If a screening test is performed within 28 days before C1D1 (unless stated otherwise) then it does not need to be repeated during rescreening.