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RSH OP PRO00036788/CAMBRIA-1 / ARM A	

Types:      Research Oncology Treatment
Synonyms:  CAMBRIA

M1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Randomization 
  --
The patient should be randomized after all screening assessments have been completed within the 28-day window, with the exception of imaging
assessment and mammogram/breast MRI which should be performed within 12 weeks and 9 months prior to randomization, respectively. Every effort
should be made to minimize the time between randomization and starting study treatment (ie, ideally on the same day but within 3 business days of
randomization). Please note that Month 1 Day 1 is defined as the day of first dose of study treatment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Medical history (past and current medical conditions) ..
---If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Patient-reported Outcomes --

Train patients on ePRO
device
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical
examination 
--If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Imaging of abdomen (± pelvis), chest, and bone must be performed prior to randomization. If done previously as part of routine standard of care, it may be used as baseline assessment provided that it is performed within 12 weeks of randomization. Additional symptom-directed scanning (such as brain imaging) may be performed if there is a suspicion of metastatic disease
		  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	PET CT WHOLE BODY	Interval: --	Occurrences: --		  	NM SPECT BONE SCAN	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If a patient with conservative surgery has not had a bilateral mammogram or breast MRI within 9 months prior to randomization, then this assessment must
be performed prior to randomization. Radiological examinations in male breast cancer patients as well as ipsilateral radiological examination in female
patients undergoing mastectomy will be replaced by clinical examination and local chest wall ultrasound as required. 
T
		  	MAMMO BREAST DIAGNOSTIC TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	12-lead ECGs--Any clinically significant abnormalities detected require triplicate ECG results (see Section 8.2.3).
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-194 (AE)
PRO-CTCAE
PGI-TT 
 
--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	VSAQ items 
 -PRO completion windows will be determined during the design process. Patients will complete the VSAQ items according to the schedule until they have responded "no" to all items for 2 consecutive timepoints
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
 
--PRO completion windows will be determined during the design process.
			Labs
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory whole
Blood pharmacogenomic
sample (PGx)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Exploratory
genetic blood
sample (optional) --The sample for genetic research will be obtained at Month 1 Day 1 pre-dose. If, for any reason, the sample is not drawn at Month 1 Day 1, it may be takenat any visit until the last study visit. Only 1 sample should be collected per patient for genetics during the study
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	At the beginning of each cycle, please ensure patient has a script for one of these medications:  Exemestane, Letrozole, Anastrozole, or Tamoxifen.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Administration per manufacturer's
instructions --
Pre- and peri-menopausal women, and men (where medically applicable), will take a concurrent LHRH agonist before or on the same day as the first dose
of study treatment, if randomized to Arm B (camizestrant). Pre- and peri-menopausal women, and men, randomized to Arm A will receive LHRH agonist
as medically applicable. Patients on LHRH agonists will have either monthly or 3-monthly injections as per investigator discretion
					
M2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Randomization 
  --
The patient should be randomized after all screening assessments have been completed within the 28-day window, with the exception of imaging
assessment and mammogram/breast MRI which should be performed within 12 weeks and 9 months prior to randomization, respectively. Every effort
should be made to minimize the time between randomization and starting study treatment (ie, ideally on the same day but within 3 business days of
randomization). Please note that Month 1 Day 1 is defined as the day of first dose of study treatment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Medical history (past and current medical conditions) ..
---If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Patient-reported Outcomes --

Train patients on ePRO
device
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical
examination 
--If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

·     Ocular examination should include visual acuity (best corrected, high and low contrast), applanation tonometry, and optical coherence tomography (OCT)
where locally available. If applanation tonometry cannot be performed (e.g. due to safety concerns) then non-contact tonometry is permitted. Ocular assessments should be performed in both treatment arms. EOT (+21 days; only if an abnormality had been reported at screening or during treatment), and Safety Follow-up (+21 days; only if the patient
discontinues treatment due to ocular toxicity)
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Imaging of abdomen (± pelvis), chest, and bone must be performed prior to randomization. If done previously as part of routine standard of care, it may be used as baseline assessment provided that it is performed within 12 weeks of randomization. Additional symptom-directed scanning (such as brain imaging) may be performed if there is a suspicion of metastatic disease
		  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	PET CT WHOLE BODY	Interval: --	Occurrences: --		  	NM SPECT BONE SCAN	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If a patient with conservative surgery has not had a bilateral mammogram or breast MRI within 9 months prior to randomization, then this assessment must
be performed prior to randomization. Radiological examinations in male breast cancer patients as well as ipsilateral radiological examination in female
patients undergoing mastectomy will be replaced by clinical examination and local chest wall ultrasound as required. 
T
		  	MAMMO BREAST DIAGNOSTIC TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	12-lead ECGs--Any clinically significant abnormalities detected require triplicate ECG results (see Section 8.2.3).
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-194 (AE)
PRO-CTCAE
PGI-TT 
 
--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	VSAQ items 
 -PRO completion windows will be determined during the design process. Patients will complete the VSAQ items according to the schedule until they have responded "no" to all items for 2 consecutive timepoints
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Labs
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	At the beginning of each cycle, please ensure patient has a script for one of these medications:  Exemestane, Letrozole, Anastrozole, or Tamoxifen.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Administration per manufacturer's
instructions --
Pre- and peri-menopausal women, and men (where medically applicable), will take a concurrent LHRH agonist before or on the same day as the first dose
of study treatment, if randomized to Arm B (camizestrant). Pre- and peri-menopausal women, and men, randomized to Arm A will receive LHRH agonist
as medically applicable. Patients on LHRH agonists will have either monthly or 3-monthly injections as per investigator discretion
					
M3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Randomization 
  --
The patient should be randomized after all screening assessments have been completed within the 28-day window, with the exception of imaging
assessment and mammogram/breast MRI which should be performed within 12 weeks and 9 months prior to randomization, respectively. Every effort
should be made to minimize the time between randomization and starting study treatment (ie, ideally on the same day but within 3 business days of
randomization). Please note that Month 1 Day 1 is defined as the day of first dose of study treatment
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Medical history (past and current medical conditions) ..
---If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Patient-reported Outcomes --

Train patients on ePRO
device
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical
examination 
--If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Imaging of abdomen (± pelvis), chest, and bone must be performed prior to randomization. If done previously as part of routine standard of care, it may be used as baseline assessment provided that it is performed within 12 weeks of randomization. Additional symptom-directed scanning (such as brain imaging) may be performed if there is a suspicion of metastatic disease
		  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		  	PET CT WHOLE BODY	Interval: --	Occurrences: --		  	NM SPECT BONE SCAN	Interval: --	Occurrences: --		  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If a patient with conservative surgery has not had a bilateral mammogram or breast MRI within 9 months prior to randomization, then this assessment must
be performed prior to randomization. Radiological examinations in male breast cancer patients as well as ipsilateral radiological examination in female
patients undergoing mastectomy will be replaced by clinical examination and local chest wall ultrasound as required. 
T
		  	MAMMO BREAST DIAGNOSTIC TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --		  	MRI BREAST W WO CONTRAST BILATERAL	Interval: --	Occurrences: --			Imaging
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	12-lead ECGs--Any clinically significant abnormalities detected require triplicate ECG results (see Section 8.2.3).
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-194 (AE)
PRO-CTCAE
PGI-TT 
 
--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	VSAQ items 
 -PRO completion windows will be determined during the design process. Patients will complete the VSAQ items according to the schedule until they have responded "no" to all items for 2 consecutive timepoints
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
 
--PRO completion windows will be determined during the design process.
			Labs
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis
			Chemotherapy
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	At the beginning of each cycle, please ensure patient has a script for one of these medications:  Exemestane, Letrozole, Anastrozole, or Tamoxifen.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Administration per manufacturer's
instructions --
Pre- and peri-menopausal women, and men (where medically applicable), will take a concurrent LHRH agonist before or on the same day as the first dose
of study treatment, if randomized to Arm B (camizestrant). Pre- and peri-menopausal women, and men, randomized to Arm A will receive LHRH agonist
as medically applicable. Patients on LHRH agonists will have either monthly or 3-monthly injections as per investigator discretion
					
M4	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical
examination 
--If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis
					
M7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Complete physical
examination 
--If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis
					
Every 3 Months Follow-Up Visit	Repeat 8 times	Cycle length: 90 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

·     Ocular examination should include visual acuity (best corrected, high and low contrast), applanation tonometry, and optical coherence tomography (OCT)
where locally available. If applanation tonometry cannot be performed (e.g. due to safety concerns) then non-contact tonometry is permitted. Ocular assessments should be performed in both treatment arms. EOT (+21 days; only if an abnormality had been reported at screening or during treatment), and Safety Follow-up (+21 days; only if the patient
discontinues treatment due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
 
--PRO completion windows will be determined during the design process.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --					
Every 6 Months Follow-Up Visit	Repeat 8 times	Cycle length: 180 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
·       If screening assessments have been performed within 7 days prior to starting study treatment, they do not have to be repeated at Month 1 Day 1 if the patient's condition has not changed
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

·     Ocular examination should include visual acuity (best corrected, high and low contrast), applanation tonometry, and optical coherence tomography (OCT)
where locally available. If applanation tonometry cannot be performed (e.g. due to safety concerns) then non-contact tonometry is permitted. Ocular assessments should be performed in both treatment arms. EOT (+21 days; only if an abnormality had been reported at screening or during treatment), and Safety Follow-up (+21 days; only if the patient
discontinues treatment due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
 
--PRO completion windows will be determined during the design process.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --					
EOT	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

·     Ocular examination should include visual acuity (best corrected, high and low contrast), applanation tonometry, and optical coherence tomography (OCT)
where locally available. If applanation tonometry cannot be performed (e.g. due to safety concerns) then non-contact tonometry is permitted. Ocular assessments should be performed in both treatment arms. EOT (+21 days; only if an abnormality had been reported at screening or during treatment), and Safety Follow-up (+21 days; only if the patient
discontinues treatment due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
 
--PRO completion windows will be determined during the design process.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis
					
Safety FUP	Repeat 1 time	Cycle length: 30 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ocular assessment 

·     Ocular examination should include visual acuity (best corrected, high and low contrast), applanation tonometry, and optical coherence tomography (OCT)
where locally available. If applanation tonometry cannot be performed (e.g. due to safety concerns) then non-contact tonometry is permitted. Ocular assessments should be performed in both treatment arms. EOT (+21 days; only if an abnormality had been reported at screening or during treatment), and Safety Follow-up (+21 days; only if the patient
discontinues treatment due to ocular toxicity)
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-171 (physical
function) 

--PRO completion windows will be determined during the design process. Month 1 Day 1
before dosing
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	PGI-S
 -PRO completion windows will be determined during the design process.
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EORTC-IL-172
(modified EORTC
QLQ-C30) --PRO completion windows will be determined during the design process.
			Nursing Orders
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	EQ-5D-5L
 
--PRO completion windows will be determined during the design process.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Disease recurrence
tumor sampled --as clinically indicated 
--Provision of a tumor biopsy collected at the time of disease recurrence is mandatory in cases where the sample is collected as part of routine clinical practice and submission for research is allowed per institutional policies. If a tumor biopsy is not routinely performed, then this sample is not required
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Mandatory blood
samples for
ctDNA analysis