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OP RESEARCH PRO00039354 SCREENING / BASELINE	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE

Screening / Baseline	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    C4391024_Mai
		  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PF-07220060, Palbociclib, Letrozole, Abemaciclib, and Ribociclib Treatment: Refer to Section 6.6 (Dose Modification): Protocol Access Hyperlink: [CG1]  C4391024_Mai

 
 [CG1]IT Beacon- Please use heading and add hyperlink:  C4391024_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Informed Consent
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Demographics/Menopausal Status for Females
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical/Oncological History
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal and neurological systems. Include clinical evaluation of superficial disease
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG PS
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Weight, blood pressure  and pulse: BP and PR will be taken before blood collection for laboratory tests and consist of a single measurement of PR and single BP measurement
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist (For pre/ perimenopausal females and males); Participants must receive treatment with an LHRH agonist prior to the first dose of study intervention (if not already ongoing)
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Contraception check
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Randomization; Study intervention must start within 2 days after randomization
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	PRO Assessments
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Serious and Nonserious AE Reporting
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior/Concomitant Medications/Treatments
		  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Every 8 weeks (±7 days) for the first 48 weeks and every 12 weeks (±7 days) thereafter from the date of randomization: C1D, C3D1, C5D1, C7D1, C9D1, C11D1, C14D1, C17D1 and subsequent every 3 cycles
		  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Every 8 weeks (±7 days) for the first 48 weeks and every 12 weeks (±7 days) thereafter from the date of randomization: C1D, C3D1, C5D1, C7D1, C9D1, C11D1, C14D1, C17D1 and subsequent every 3 cycles
		  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Every 8 weeks (±7 days) for the first 48 weeks and every 12 weeks (±7 days) thereafter from the date of randomization: C1D, C3D1, C5D1, C7D1, C9D1, C11D1, C14D1, C17D1 and subsequent every 3 cycles, Within 28 days before randomization
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Tumor Assessments; X-ray chest CT; brain (if applicable), abdomen and pelvis CT or MRI. The CT and MRI scans should be with contrast unless contraindicated.
PET/CT should not be a substitute for CT or MRI unless the CT component is of similar diagnostic quality as a CT performed without PET, Every 8 weeks (±7 days) for the first 48 weeks and every 12 weeks (±7 days) thereafter from the date of randomization: C1D, C3D1, C5D1, C7D1, C9D1, C11D1, C14D1, C17D1 and subsequent every 3 cycles
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Local lab may be sent when results are time-sensitive (eg, for participant safety or adjustment of study intervention dose or schedule
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Local lab may be sent when results are time-sensitive (eg, for participant safety or adjustment of study intervention dose or schedule
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	Local lab may be sent when results are time-sensitive (eg, for participant safety or adjustment of study intervention dose or schedule
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	Local lab may be sent when results are time-sensitive (eg, for participant safety or adjustment of study intervention dose or schedule
		  	CYSTATIN C WITH EGFR	Interval: --	Occurrences: --	Comments:	Postbaseline, serum cystatin C is measured if and only if serum creatinine increase postbaseline is observed
		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Local lab may be sent when results are time-sensitive (eg, for participant safety or adjustment of study intervention dose or schedule
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Only for postmenopausal state in females under 60 years old not on LHRH
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	As applicable for WOCBP
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Retained Research Sample for Genetics (predose)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tumor Tissue for Biomarker; Provision of available tumor tissue at baseline if possible