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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04975308
Registration number
NCT04975308
Ethics application status
Date submitted
22/07/2021
Date registered
23/07/2021
Date last updated
11/07/2025
Titles & IDs
Public title
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
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Scientific title
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
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Secondary ID [1]
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0
J2J-OX-JZLC
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Secondary ID [2]
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0
18175
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Universal Trial Number (UTN)
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Trial acronym
EMBER-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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0
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Neoplasm Metastasis
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Condition category
Condition code
Cancer
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Imlunestrant
Treatment: Drugs - Exemestane
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Abemaciclib
Experimental: Arm A: Imlunestrant - Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
Experimental: Arm B: Investigator's Choice of Endocrine Therapy - Participants received the investigator's choice of endocrine therapy, either exemestane 25 mg administered orally once daily on days 1 to 28 of a 28-day cycle, or Fulvestrant 500 mg intramuscularly on days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond, until disease progression or a criterion for discontinuation was met.
Experimental: Arm C: Imlunestrant + Abemaciclib - Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
Treatment: Drugs: Imlunestrant
Administered orally.
Treatment: Drugs: Exemestane
Administered orally.
Treatment: Drugs: Fulvestrant
Administered IM.
Treatment: Drugs: Abemaciclib
Administered orally.
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
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Assessment method [1]
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PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [1]
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Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
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Primary outcome [2]
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Investigator-assessed PFS (Between Arm C and Arm A)
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Assessment method [2]
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PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [2]
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Randomization to the date of first documented progression of disease or death from any cause (up to 26 months)
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Primary outcome [3]
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Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B)
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Assessment method [3]
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PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [3]
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0
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
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Secondary outcome [1]
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Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm A and Arm B)
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Assessment method [1]
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PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [1]
0
0
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
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Secondary outcome [2]
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0
Blinded Independent Review Committee (BIRC) Assessed PFS (Between Arm C and Arm A)
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Assessment method [2]
0
0
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [2]
0
0
Randomization to the date of first documented progression of disease or death from any cause (up to 25 months)
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Secondary outcome [3]
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Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm A and Arm B)
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Assessment method [3]
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ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
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Timepoint [3]
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Randomization until measured progressive disease (up to 28 months)
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Secondary outcome [4]
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Investigator-assessed Duration of Response (DoR) (Between Arm A and Arm B)
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Assessment method [4]
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DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [4]
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0
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
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Secondary outcome [5]
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Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm A and Arm B)
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Assessment method [5]
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CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (=) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [5]
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0
Randomization until measured progressive disease (up to 28 months)
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Secondary outcome [6]
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0
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) (Between Arm C and Arm A)
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Assessment method [6]
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ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
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Timepoint [6]
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0
Randomization until measured progressive disease (up to 26 months)
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Secondary outcome [7]
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Investigator-assessed Duration of Response (DoR) (Between Arm C and Arm A)
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Assessment method [7]
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DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [7]
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0
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
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Secondary outcome [8]
0
0
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) (Between Arm C and Arm A)
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Assessment method [8]
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0
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (=) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [8]
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0
Randomization until measured progressive disease (up to 26 months)
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Secondary outcome [9]
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Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm A and Arm B)
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Assessment method [9]
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Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (=2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
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Timepoint [9]
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0
Randomization through follow-up (up to 24 months)
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Secondary outcome [10]
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Time to Sustained Worsening of the "Worst Pain" as Measured by Worst Pain NRS (Between Arm C and Arm A)
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Assessment method [10]
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Time to sustained worsening of worst pain is defined as the time from randomization to the first increase (=2 points) in the weekly average of the worst pain score, with confirmation in the next consecutive week. It was measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single-item, participant-administered, 11-point horizontal scale ranging from 0 to 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine." Participants not known to have sustained worsening will be censored at the last documented assessment.
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Timepoint [10]
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Randomization through follow-up (up to 20 months)
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Secondary outcome [11]
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Pharmacokinetics (PK): Plasma Concentration of Imlunestrant
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Assessment method [11]
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* Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing. * For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
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Timepoint [11]
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Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
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Secondary outcome [12]
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Pharmacokinetics (PK): Plasma Concentration of Total Abemaciclib
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Assessment method [12]
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* Plasma concentration of total abemaciclib is the concentration of the parent abemaciclib and its metabolites in the plasma. * Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing. * For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
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Timepoint [12]
0
0
Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
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Secondary outcome [13]
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0
Overall Survival (OS) in the ITT Population
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Assessment method [13]
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OS in the ITT population
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Timepoint [13]
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Randomization until death from any cause (estimated as up to 5 years)
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Secondary outcome [14]
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OS in the ESR1-mutation Detected Population
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Assessment method [14]
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OS in the ESR1-mutation detected population
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Timepoint [14]
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Randomization until death from any cause (estimated as up to 5 years)
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Secondary outcome [15]
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0
Blinded Independent Review Committee (BIRC) Assessed PFS in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
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Assessment method [15]
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0
PFS was defined as the time from randomization to the date of first documented progression of disease or death from any cause in the absence of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria, as assessed by investigator. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [15]
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0
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months)
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Secondary outcome [16]
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0
Percentage of Participants With Investigator-assessed Objective Response Rate (ORR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
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Assessment method [16]
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0
ORR was the best confirmed overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
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Timepoint [16]
0
0
Randomization until measured progressive disease (up to 28 months)
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Secondary outcome [17]
0
0
Investigator-assessed Duration of Response (DoR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
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Assessment method [17]
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DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).
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Timepoint [17]
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0
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months)
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Secondary outcome [18]
0
0
Percentage of Participants With Investigator-assessed Clinical Benefit Rate (CBR) in the ESR1-Mutation Detected Population (Between Arm A and Arm B)
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Assessment method [18]
0
0
CBR was the best confirmed overall tumor response of stable disease (SD) for greater than or equal to (=) 24 weeks, CR or PR as defined by RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [18]
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Randomization until measured progressive disease (up to 28 months)
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Eligibility
Key inclusion criteria
* Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
* Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
* Must be deemed appropriate for treatment with endocrine therapy
* If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
* Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
* Have adequate renal, hematologic, and hepatic organ function
* Must be able to swallow capsules/tablets
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
* Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
* Have symptomatic or untreated brain metastasis.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
* Known allergic reaction against any of the components of the study treatment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
874
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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0
St Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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0
Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
0
0
Ashford Cancer Centre Research - Kurralta Park
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Recruitment hospital [4]
0
0
Box Hill Hospital - Box Hill
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Recruitment hospital [5]
0
0
Maroondah Hospital - Melbourne
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Recruitment postcode(s) [1]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [2]
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0
4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5037 - Kurralta Park
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Recruitment postcode(s) [4]
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0
3128 - Box Hill
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Recruitment postcode(s) [5]
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0
3135 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
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0
California
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0
0
United States of America
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0
Colorado
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0
0
United States of America
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0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Hawaii
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0
0
United States of America
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State/province [6]
0
0
Illinois
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0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kentucky
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Country [9]
0
0
United States of America
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State/province [9]
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0
Mississippi
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0
0
United States of America
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State/province [10]
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0
New Jersey
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Country [11]
0
0
United States of America
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State/province [11]
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0
New York
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Country [12]
0
0
United States of America
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State/province [12]
0
0
North Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Ohio
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Country [14]
0
0
United States of America
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State/province [14]
0
0
South Dakota
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Tennessee
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Texas
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Utah
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Vermont
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Country [19]
0
0
Argentina
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State/province [19]
0
0
Buenos Aires
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Country [20]
0
0
Argentina
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State/province [20]
0
0
Ciudad Autónoma De Buenos Aires
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Country [21]
0
0
Argentina
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State/province [21]
0
0
Córdoba
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Country [22]
0
0
Argentina
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State/province [22]
0
0
RÃo Negro
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Country [23]
0
0
Argentina
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State/province [23]
0
0
San Juan
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Country [24]
0
0
Argentina
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State/province [24]
0
0
Santiago del Estero
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Country [25]
0
0
Austria
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State/province [25]
0
0
Steiermark
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Country [26]
0
0
Austria
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State/province [26]
0
0
Wien
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Country [27]
0
0
Austria
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State/province [27]
0
0
Salzburg
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Country [28]
0
0
Belgium
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State/province [28]
0
0
Antwerpen
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Country [29]
0
0
Belgium
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State/province [29]
0
0
Bruxelles-Capitale, Région De
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Country [30]
0
0
Belgium
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State/province [30]
0
0
Oost-Vlaanderen
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Country [31]
0
0
Belgium
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State/province [31]
0
0
Vlaams-Brabant
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Country [32]
0
0
Belgium
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State/province [32]
0
0
West-Vlaanderen
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Country [33]
0
0
Belgium
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State/province [33]
0
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Namur
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Brazil
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Brazil
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São Paulo
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China
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Anhui
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China
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Beijing
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China
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Fujian
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China
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Guangdong
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Shaanxi
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China
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Shandong
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Czechia
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Beroun
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Czechia
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Praha 10
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Czechia
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Czechia
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Czechia
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France
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France
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France
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Doubs
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France
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France
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Paris
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France
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Hessen
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AttikÃ
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India
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Italy
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Italy
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Italy
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Italy
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Kalužskaja Oblast'
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Russian Federation
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Madrid, Comunidad De
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Mersin
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Zakarpatska Oblast
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
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Trial website
https://clinicaltrials.gov/study/NCT04975308
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
0
0
Eli Lilly and Company
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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Address
0
0
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Country
0
0
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Phone
0
0
1-317-615-4559
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/08/NCT04975308/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/08/NCT04975308/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04975308
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