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OP RSH PRO00036451 NAIR ML43171 GIREDESTRANT EXPERIMENTAL ARM A	

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

Take-Home medications	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Take-Home Medications Prior to Treatment
  	dexAMETHasone 0.5 mg/5 mL solution	Dose: 1 mg	Route: oral	4 times daily	Dispense: --	Refills: --	Start: S			Instructions:	10 mL swished for 2 minutes and spit four times a day. Start concurrently with study treatment for 8 weeks, and use as needed thereafter with the first appearance of symptoms. No food or drink is to be consumed for at least 1 hour after swishing and spitting the dexamethasone mouthwash.					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Patients should receive their first dose of study treatment on the day of randomization  if possible, but no later than 3 business days after randomization. Allowed window ±3 days 
EOT : 30 days after final dose  ±3 days
PRO Fup : 90 days after treatment discontinuation ±7 days
FUP : every 6 months
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	SDOH Questionnaire.

Cycle 1 Day 1 only.
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Limited physical examination 

Perform a limited, symptom-directed examination at specified post-baseline timepoints and as clinically indicated at other timepoints.
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	ECOG performance status
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23 (males exempt)
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
				Day 15	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
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Limited physical examination 

Perform a limited, symptom-directed examination at specified post-baseline timepoints and as clinically indicated at other timepoints.
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
					
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
				Day 15	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
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Limited physical examination 

Perform a limited, symptom-directed examination at specified post-baseline timepoints and as clinically indicated at other timepoints.
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	ZZURINALYSIS, MICRO UA SCREEN WITH MICROSCOPY	Interval: --	Occurrences: --	Comments:	As clinically indicated
		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --	Comments:	as clinically indicated
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --	Comments:	as clinically indicated
			Labs
  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23 (males exempt)
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Bone scans are to be repeated every 24 weeks (±7 days) in patients with bone lesions at baseline or as clinically indicated. Evaluable bone lesions should be followed as per RECIST v1.1 every 8 weeks (±7days) after Cycle 1, Day 1 for the first 18 months and every 12 weeks (± 7 days) thereafter until disease progression.
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	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.
			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23 (males exempt)
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Bone scans are to be repeated every 24 weeks (±7 days) in patients with bone lesions at baseline or as clinically indicated. Evaluable bone lesions should be followed as per RECIST v1.1 every 8 weeks (±7days) after Cycle 1, Day 1 for the first 18 months and every 12 weeks (± 7 days) thereafter until disease progression.
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 14	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 15	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 17	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 18	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 19	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Bone scans are to be repeated every 24 weeks (±7 days) in patients with bone lesions at baseline or as clinically indicated. Evaluable bone lesions should be followed as per RECIST v1.1 every 8 weeks (±7days) after Cycle 1, Day 1 for the first 18 months and every 12 weeks (± 7 days) thereafter until disease progression.
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 21	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 22	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 23	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
Cycle 24	Repeat 1 time	Cycle length: 28 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	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.
			Labs
  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
		  	ESTRADIOL LEVEL	Interval: --	Occurrences: --	Comments:	if receiving an LHRH agonist.
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23 (males exempt)
			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Chemotherapy
  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Giredestrant 30 mg PO QD 

Giredestrant will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Take with or without food. Swallow whole with a glass of water and should not be chewed, cut, or crushed. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges. If a dose is missed it should be made up unless the next dose is due within 6 hours. If the patient vomits at any time after taking a dose, an additional dose should not be taken that day.
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	INV-Everolimus 10MG PO  once daily.

Everolimus will be administered in the clinic on Day 1 and Day 15 of Cycle 1. On those days, it will be administered in the clinic after study assessments have been completed. On D1 of each subsequent cycle, patients will hold dose until after the clinic visit. Admin instructions: Take with a glass of water, either with or without food. Patients should be instructed to swallow tablets whole, and not to chew or crush them. Avoid grapefruit/grapefruit juice/grapefruit supplements and Seville oranges
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	LHRH agonist. Premenopausal/perimenopausal patients and male patients PI will determine the choice.  Doses should always be given on D1 of each cycle when possible to minimize the number of clinic visits.
					
End of treatment (EOT)	Repeat 1 time	Cycle length: 30 days	Day 1	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
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	ECGs will be obtained prior to other medical procedures scheduled at that same time (e.g., vital sign measurements, blood draws) whenever feasible. A single ECG will be performed, and clinically significant abnormalities will be confirmed by triplicate reading
			Baseline
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	Tumor assessment: CT, MRI, clinical

At subsequent tumor assessment time points, brain scans should be acquired if disease was present at baseline or if clinically indicated. Response must be assessed by the investigator according to RECIST v1.1. Patients who discontinue study treatment for any reason other than disease progression or death will continue to undergo tumor-response evaluations until progressive disease or the initiation of another anti-cancer therapy, whichever occurs first
			Imaging
  	NM BONE SCAN WHOLE BODY	Interval: --	Occurrences: --	Comments:	Bone scans are to be repeated every 24 weeks (±7 days) in patients with bone lesions at baseline or as clinically indicated. Evaluable bone lesions should be followed as per RECIST v1.1 every 8 weeks (±7days) after Cycle 1, Day 1 for the first 18 months and every 12 weeks (± 7 days) thereafter until disease progression.
			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.   Continuously until discontinuation visit.  

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
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Medication diary 

Complete when medication is taken at home or at clinic visit
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Measure  Weight
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Complete blood count should be available for review prior to dosing to inform dosing decisions.
		  	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: --			Labs
  	BIOMARKERS WITH NO ALTERATIONS (QUEST REFLEX)	Interval: --	Occurrences: --	Comments:	See appendix 3
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23 (males exempt)
					
Follow up [Fup]	Repeat 3 times	Cycle length: 168 days	Day 1	Perform every 180 days 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
			Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Survival and new anti-cancer therapy follow-up 

After treatment discontinuation, 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 (or more frequently, if required) until death (unless the patient withdraws consent or the Sponsor terminates the study). If a patient requests to be withdrawn from follow-up, this request must be documented in the source documents and signed by the investigator. If the patient withdraws from the study, the study staff may use a public information source (e.g., county records) to obtain information about survival status.
			Nursing Orders
  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO assessments will be completed before the patient receives any information on disease status and prior to the performance of non-PRO assessments and the administration of study treatment. Questionnaires will be completed at the following timepoints and in the order listed below. All PROs will be completed at the treatment discontinuation visit
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	PRO-CTCAE and FACT-G GP5
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-C30, BPI-SF "worst pain" item, EQ-5D-5L
		  	ONC NURSING COMMUNICATION 104	Interval: --	Occurrences: --	Comments:	EORTC QLQ-BR23 (males exempt)