Protocol Index	

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RESEARCH PRO00026231 / NIRAVATH BO41843 ROCHE PHASE III RANDOMIZED DOUBLE-BLIND	

Types:      Research Oncology Treatment
Synonyms:  GDC-9545, PALBOCICLIB, LETROZOLE, HER2-NEGATIVE, ESTROGEN RECEPTOR-POSITIVE

Screening/Baseline (Day –28 to Day –1)	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate, rested in supine position for at least 10 minutes.
			Cardiology
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	For premenopausal patients and patients aged LESS than 60 years.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for women of childbearing potential.
		  	LDH	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nuclear Medicine
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Tumor Assessment; Every 24 weeks (+/-7 days) from randomization or 12 weeks if evaluable.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Every 12 weeks (+/- 7 days) from randomization.
		  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Required at screening only if clinically indicated or when a patient had previously treated brain lesions.
					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1 (+/- 3 days)	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate, rested in supine position for at least 10 minutes.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for women of childbearing potential within 7 days before treatment.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	For premenopausal patients and patients aged LESS than 60 years.  Day 1 of each cycle for 3 cycles if receiving LHRH agonist.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nuclear Medicine
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Tumor Assessment; Every 24 weeks (+/-7 days) from randomization or 12 weeks if evaluable.
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Every 12 weeks (+/- 7 days) from randomization.
			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	GDC-9545 30 mg/placebo and Letrozole/placebo 2.5mg (one will be active, and the other will be placebo, staff are blinded) administration QD Days 1-28 of each cycle.  Administered at clinic visits (Day 1 of each cycle); otherwise administered at home.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Palbociclib 125mg QD Days 1-21 of each cycle.  Administered at clinic visits (Day 1 of each cycle); otherwise administered at home.
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	LHRH agonist administration (for premenopausal and male patients).  Administered at clinic visit on Day 1 of each cycle.
				Day 15 (+/- 3 days)	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate, rested in supine position for at least 10 minutes.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 2 (+/- 3 days)	Repeat 1 time	Cycle length: 28 days	Day 1 (+/- 3 days)	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate, rested in supine position for at least 10 minutes.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for women of childbearing potential.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	For premenopausal patients and patients aged LESS than 60 years.  Day 1 of each cycle for 3 cycles if receiving LHRH agonist.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	GDC-9545 30 mg/placebo and Letrozole/placebo 2.5mg (one will be active, and the other will be placebo, staff are blinded) administration QD Days 1-28 of each cycle.  Administered at clinic visits (Day 1 of each cycle); otherwise administered at home.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Palbociclib 125mg QD Days 1-21 of each cycle.  Administered at clinic visits (Day 1 of each cycle); otherwise administered at home.
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	LHRH agonist administration (for premenopausal and male patients).  Administered at clinic visit on Day 1 of each cycle.
				Day 15 (+/- 3 days)	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
Cycle 3 and Beyond	Repeat 1 time	Cycle length: 28 days	Day 1  (+/- 3 days)	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 116	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate, rested in supine position for at least 10 minutes.  Day 1 of Cycle 4, then every 4 cycles thereafter (Cycles 8, 12, 16, etc.).
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --	Comments:	Fasting; On Day 1 of Cycle 4 and every four cycles thereafter (Cycles 8, 12, etc.).
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for women of childbearing potential.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	For premenopausal patients and patients aged LESS than 60 years.  Day 1 of each cycle for 3 cycles if receiving LHRH agonist.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	GDC-9545 30 mg/placebo and Letrozole/placebo 2.5mg (one will be active, and the other will be placebo, staff are blinded) administration QD Days 1-28 of each cycle.  Administered at clinic visits (Day 1 of each cycle); otherwise administered at home.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Palbociclib 125mg QD Days 1-21 of each cycle.  Administered at clinic visits (Day 1 of each cycle); otherwise administered at home.
		  	ONC PROVIDER COMMUNICATION 3	Interval: --	Occurrences: --	Comments:	LHRH agonist administration (for premenopausal and male patients).  Administered at clinic visit on Day 1 of each cycle.
					
Treatment Discontinuation 30 Days after Final Dose	Repeat 1 time	Cycle length: 1 day	Day 1 (+3 days)	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, temperature, respiratory rate, pulse
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate, rested in supine position for at least 10 minutes.
			Cardiology
  	CV ECHOCARDIOGRAM RESEARCH ONLY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Only for women of childbearing potential within 7 days before treatment.
					
Follow-Up (every 6 months +/-7 days)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Information on survival follow-up and new anti-cancer therapy will be collected via telephone calls, patient medical records, and/or clinic visits approximately every 6 months until death.