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OP RSH PRO00036451 NAIR ML43171 GIREDESTRANT SCREENING	

Types:      Research Oncology Treatment
Synonyms:  GIREDESTRANT, EVEROLIMUS, EXEMESTANE, METASTATIC BREAST CANCER , ADVANCED BREAST CANCER, NCT05306340, PRO00036451, ML43171

Screening/Baseline 	Repeat 1 time	Cycle length: 28 days	Screening	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events :Appendix 1 
Calendar for sequence of diagnostic tests, examinations, and treatment administration.  See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:  ML43171_GIREDESTRANT protocol v2_06Jul2022.pdf
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Giredestrant Treatment:  Refer to Section 5.1.1  
Protocol Access Hyperlink:  ML43171_GIREDESTRANT protocol v2_06Jul2022.pdf
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Exemestane Treatment:  Refer to Section 5.1.4  
Protocol Access Hyperlink: ML43171_GIREDESTRANT protocol v2_06Jul2022.pdf
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for Everolimus  Treatment : : Refer to Section  5.1.2
Protocol Access Hyperlink:  ML43171_GIREDESTRANT protocol v2_06Jul2022.pdf
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Laboratory samples should be drawn within 72 hours prior to study drug administration (except for the blood sample for ESR1 mutation status, which should be collected 20 days prior to the expected Cycle 1 Day 1). All other results of standard-of-care tests or examinations performed prior to obtaining informed consent and within 28 days prior to Day 1 of Cycle 1 may be used (except bone scans - see footnote regarding bone scans for details); such tests do not need to be repeated for screening, unless otherwise indicated.
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Informed consent: Informed consent must be documented before any study-specific screening procedure is performed and may be obtained up to 28 days before initiation of study treatment. Screen failed patients should re-sign the ICF before being re-screened
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Demographic data
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Medical history and baseline conditions
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Complete physical examination
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	ECOG performance status
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Blood collection for ESR1 mutation status.  

Blood collection for ESR1 mutation status must occur at least 20 days prior to the expected Cycle 1 Day 1 so that results are available for stratification prior to randomization. If rescreening, blood for ESR1 status does not need to be recollected at baseline.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	At Screening: Triplicate ECG
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

All screening tumor assessments should be completed within 28 days prior to randomization. Brain CT/MRI is required at screening only if clinical indicated or when a patient had previously treated brain lesions
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Bone scan to be performed at screening or if available, prior bone scans (obtained as part of routine clinical care) within 6 weeks before randomization is also acceptable.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Concomitant medication.

Medication (e.g., prescription drugs, over-the-counter drugs, vaccines, herbal or homeopathic remedies, nutritional supplements) used by a patient in addition to protocol-mandated treatment from 7 days prior to initiation of study treatment until the treatment discontinuation visit.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Adverse events.

After informed consent has been obtained but prior to initiation of study treatment, only serious adverse events caused by a protocol-mandated intervention should be reported. After initiation of study treatment, all adverse events will be reported until 30 days after the final dose of study treatment. After this period, the Sponsor should be notified if the investigator becomes aware of any serious adverse event that is believed to be related to prior exposure to study drug treatment
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure Height and Weight
				Baseline/Screening 7 days before	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Hematology includes WBC count, RBC count, hemoglobin, hematocrit, platelet count, and differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes, other cells). Complete blood count should be available for review prior to dosing to inform dosing decisions
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Chemistry panel (serum or plasma) includes sodium, potassium, chloride, glucose, BUN or urea, creatinine, total protein, albumin, phosphate, calcium, total and direct bilirubin, ALP, ALT, AST, urate, LDH, and bicarbonate or total carbon dioxide (if considered standard of care for the region). BUN, creatinine, bilirubin, ALP, ALT, AST count should be available for review prior to dosing to inform dosing decisions.
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting lipid panel (cholesterol, HDL, LDL, and triglyceride) will be assessed after greater than or equal to 8 hours of fasting.
		  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --	Comments:	Fasting (= 8-hour fast) glucose sample. For patients who are diabetic, fasting glucose should be done at baseline and as often as needed per investigator's discretion. For patients who are not diabetic, fasting glucose should be done at baseline and annually thereafter.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Applicable for pre-and perimenopausal women and men and women receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	Applicable for pre-and perimenopausal women and women receiving an LHRH agonist.
		  	ZZURINALYSIS, MICRO UA SCREEN WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	Urinalysis includes dipstick (pH, specific gravity, glucose, protein, ketones, blood) and microscopic examination (sediment, RBCs, WBCs, casts, crystals, epithelial cells, bacteria).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	All women of childbearing potential will have a serum pregnancy test at screening, within 7 days prior to initiation of study treatment. Urine pregnancy tests will be performed at specified subsequent visits, starting at Day 1 of Cycle 2. If a urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. Pregnancy test should be available for review prior to dosing to inform dosing decisions.
			Labs
  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --