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OP RSH PRO00045409 J2J-MC-JZLL MAI SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00045409 J2J-MC-JZLL MAI, J2J-MC-JZLL MAI

Baseline/Screening	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING 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:    J2J-MC-JZLL_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Imlunestrant: Refer to Section 6.6. Protocol Access Hyperlink:    J2J-MC-JZLL_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Medical history and description of primary breast cancer
		  	ONC NURSING COMMUNICATION 30	Interval: --	Occurrences: --	Comments:	Tumor measurement
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Adverse events collection
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Urinalysis - AS CLINICALLY INDICATED
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Record ECGs before collecting blood
		  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Menstrual cycle information
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum pregnancy test required for participants of childbearing potential GREATER THAN OR EQUAL TO 7 days prior to V1.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Imaging
  	BONE DENSITY	Interval: --	Occurrences: --	Comments:	Only for cohort 2.
			Imaging
  	US PELVIC TRANSVAGINAL	Interval: --	Occurrences: --	Comments:	Only for cohort 2.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Breast tumor tissue. Only for cohort 1.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hormones