Protocol Index	

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OP RSH GO42784 (NASBP B-61) GIREDESTRANT/JAIN SCREENING	

Types:      Research Oncology Treatment
Synonyms:  LIDERA, GIREDESTRANT, G042784, CC0014

Screening Assessments (Day -28 to Randomization)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	while seated
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	TRANSFUSION REACTION EVALUATION	Interval: --	Occurrences: --	Comments:	Evaluation of head, eyes, ears, nose, throat, also systems: cardiovascular, dermatologic, musculoskeletal, respiratory, abdominal, gastrointestinal, neurologic and genitourinary with ECOG Performace status
			Imaging
  	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Bilateral mammogram or breast MRI within 8 months of randomization
		  	MAMMO DIGITAL DIAGNOSTIC BILATERAL	Interval: --	Occurrences: --	Comments:	Bilateral mammogram or breast MRI within 8 months of randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Clinical examination of breast/chest wall and axilla
			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Baseline tumor staging (i.e., full body bone imaging per standard clinical practice, chest, abdominal ± pelvic imaging) must be completed within 28 days prior to randomization for participants stratified high risk
			Cardiology
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Single ECG, but abnormalities to be confirmed with ECG in triplicate
			Imaging
  	DXA BONE DENSITY EXTERNAL STUDY	Interval: --	Occurrences: --			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	WBC count, RBC count, hemoglobin, hematocrit, platelet count, and differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes, and other cells)
		☑	BASIC METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	§  sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, calcium, total bilirubin (if total bilirubin is 2x ULN, also record direct bilirubin), ALP, ALT, AST
		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	LIPID PANEL	Interval: --	Occurrences: --	Comments:	After fasting of 8 hours - cholesterol, HDL, LDL, triglycerides
		☑	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Applicable for pre-and perimenopausal women, women < 60 years old, and men and women receiving an LHRH agonist
		☑	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	Applicable for pre-and perimenopausal women, women < 60 years old, and women receiving an LHRH agonist
		☑	URINALYSIS, MICRO UA SCREEN WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Dipstick - pH, specific gravity, glucose, protein, ketones, and blood
Microscopic - sediment, RBC, WBC, casts, crystals, epithelial cells, and bacteria
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Serum test to be done within 7 days of treatment start and urine test within 24 hours of treatment start for all women of childbearing potential. Positive urine test to be confirmed with serum test
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Serum test to be done within 7 days of treatment start and urine test within 24 hours of treatment start for all women of childbearing potential. Positive urine test to be confirmed with serum test
			Nursing Orders
  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Confirmed availability of an untreated breast tumor tissue specimen that is suitable for biomarker assessments is required during screening
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	LHRH administration if applicable
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Concomitant medication review
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Review