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Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer (AMEERA-5)

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amcenestrant-matching placebo
SAR439859
Palbociclib
Letrozole
Goserelin
Letrozole-matching placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

  • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • No prior systemic treatment for loco-regional recurrent or metastatic disease
  • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants should be willing to provide tumor tissue
  • Capable of giving informed consent

Exclusion criteria:

  • Known active brain metastases
  • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
  • Inadequate organ and marrow function
  • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
  • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
  • Male participants who disagree to follow contraception
  • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
  • Participants with significant concomitant illness

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number :8400075
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amcenestrant with Letrozole-matching placebo Arm

Letrozole with Amcenestrant matching placebo Arm

Arm Description

Participants in Amcenestrant with Letrozole-matching placebo Arm will be administered: Amcenestrant dose, once daily, continuously. Letrozole-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle. Goserelin once every 4 weeks in pre/peri menopausal women and men

Participants in Letrozole with Amcenestrant-matching placebo Arm will be administered: Letrozole dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle Goserelin once every 4 weeks in pre/peri menopausal women and men

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.

Secondary Outcome Measures

Overall Survival (OS)
OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.
12-month Progression-free Survival (PFS) Rate
Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization.
Percentage of Participants With Objective Response
Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Duration of Response (DOR)
DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Percentage of Participants With Clinical Benefit
Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions & normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.
Progression-free Survival on Next Line of Therapy (PFS2)
PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Pharmacokinetics: Plasma Concentrations of Amcenestrant
Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol.
Pharmacokinetics: Plasma Concentrations of Palbociclib
Palbociclib plasma concentrations at specified time points were reported.
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, & Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) & GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL=higher level of functioning, & higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported in this outcome measure.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact & side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales & single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) & 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, & upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean & SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value & stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores
EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported.
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score
EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for VAS was reported in this outcome measure.
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score
EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) & VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, & extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state & lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for health utility index value score was reported in this outcome measure.
Time to First Chemotherapy
Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression.
Number of Participants With Hematological Abnormalities During the Treatment Period
Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment.
Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period
Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure.

Full Information

First Posted
July 10, 2020
Last Updated
June 13, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04478266
Brief Title
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Acronym
AMEERA-5
Official Title
A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
May 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: To compare the overall survival in both treatment arms. To evaluate the objective response rate in both treatment arms. To evaluate the duration of response in both treatment arms. To evaluate the clinical benefit rate in both treatment arms. To evaluate progression-free survival on next line of therapy. To evaluate the pharmacokinetics of amcenestrant, and palbociclib. To evaluate health-related quality of life in both treatment arms. To evaluate the time to first chemotherapy in both treatment arms. To evaluate safety in both treatment arms.
Detailed Description
Study duration per participant is approximately 59 months, which includes a 33- month treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1068 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amcenestrant with Letrozole-matching placebo Arm
Arm Type
Experimental
Arm Description
Participants in Amcenestrant with Letrozole-matching placebo Arm will be administered: Amcenestrant dose, once daily, continuously. Letrozole-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle. Goserelin once every 4 weeks in pre/peri menopausal women and men
Arm Title
Letrozole with Amcenestrant matching placebo Arm
Arm Type
Active Comparator
Arm Description
Participants in Letrozole with Amcenestrant-matching placebo Arm will be administered: Letrozole dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously. Palbociclib dose once daily, days 1-21 of every 28-day cycle Goserelin once every 4 weeks in pre/peri menopausal women and men
Intervention Type
Drug
Intervention Name(s)
Amcenestrant-matching placebo
Intervention Description
Pharmaceutical form: Tablets Route of Administration: Oral
Intervention Type
Drug
Intervention Name(s)
SAR439859
Other Intervention Name(s)
Amcenestrant
Intervention Description
Pharmaceutical form: Tablets Route of Administration: Oral
Intervention Type
Drug
Intervention Name(s)
Palbociclib
Other Intervention Name(s)
Ibrance
Intervention Description
Pharmaceutical form: Capsules/Tablets Route of Administration: Oral
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Pharmaceutical form: Capsules Route of Administration: Orally
Intervention Type
Drug
Intervention Name(s)
Goserelin
Intervention Description
Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Letrozole-matching placebo
Intervention Description
Pharmaceutical form: Capsules Route of Administration: Orally
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Time Frame
From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum exposure: 81 weeks)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the interval (in months) from the date of randomization to the date of documented death (due to any cause). In the absence of observation of death, survival time was censored to last date the participant was known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.
Time Frame
From randomization to the death due to any cause or data cut-off date, whichever comes first (maximum exposure: 81 weeks)
Title
12-month Progression-free Survival (PFS) Rate
Description
Percentage of participants who were disease progression-free at Month 12 after randomization were reported in this outcome measure. PFS was defined as the time interval (in months) from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by local radiologist or investigator, or death (due to any cause), whichever comes first. PD as per RECIST 1.1: at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. The PFS rate at Month 12 was estimated using the Kaplan-Meier method and provided an estimation of the percentage of participants who were disease progression-free at Month 12 after randomization.
Time Frame
Month 12
Title
Percentage of Participants With Objective Response
Description
Objective response was defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by investigator. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30%decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
Time Frame
From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum exposure: 81 weeks)
Title
Duration of Response (DOR)
Description
DOR was defined as time (in months) from first documented evidence of CR or PR until disease progression determined by investigator as per RECIST 1.1, or start of any anti-cancer therapy, or death from any cause, whichever occurs first. For participants with ongoing response at the time of the analysis, DOR was censored at the date of the last valid disease assessment not showing documented progression performed before the initiation of a new anticancer treatment (if any). As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Time Frame
From the date of first response of CR or PR until disease progression or death, or start of any anti-cancer therapy or data cut-off date, whichever comes first (maximum exposure: 81 weeks)
Title
Percentage of Participants With Clinical Benefit
Description
Clinical Benefit was defined as the percentage of participants having a confirmed CR, PR, or stable disease (SD) for at least 24 weeks determined by investigator as per RECIST 1.1, from date of randomization until disease progression, or death, or data cut-off date, or initiation of post treatment anti-cancer therapy, whichever occurs first. As per RECIST 1.1; CR was defined as disappearance of all target, non-target lesions & normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference Baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.
Time Frame
From randomization until disease progression, or death, or data cut-off date, whichever comes first (maximum exposure: 81 weeks)
Title
Progression-free Survival on Next Line of Therapy (PFS2)
Description
PFS2 was defined as the time interval (in months) from the date of randomization to the date of first documentation of PD on the next systemic anti-cancer therapy according to investigator, or death due to any cause in the absence of documented PD on the next systemic anti-cancer therapy, whichever occurs first. PD was defined as at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method.
Time Frame
From randomization to date first documented disease progression on the next systemic anti-cancer therapy, or death due to any cause, or data cut-off date, whichever comes first (maximum exposure: 81 weeks)
Title
Pharmacokinetics: Plasma Concentrations of Amcenestrant
Description
Amcenestrant plasma concentrations at specified time points were reported. Data for this outcome measure was not planned to be collected and analyzed for Letrozole+Palbociclib arm as pre-specified in protocol.
Time Frame
Cycle 1 Day 1: 3 hours (hr) post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose
Title
Pharmacokinetics: Plasma Concentrations of Palbociclib
Description
Palbociclib plasma concentrations at specified time points were reported.
Time Frame
Cycle 1 Day 1: 3 hr post-dose, Cycle 1 Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 3 hr post-dose, Cycle 2 Day 15: pre-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 7 Day 1: pre-dose, Cycle 10 Day 1: pre-dose
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores
Description
EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. These include 5 functional scales, 9 symptom scales, & Global Health Status/quality of life scale (GHS/QoL). All 14 items/domains were scored on scale of 1 (not at all) to 4 (very much) & GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional & GHS/QoL=higher level of functioning, & higher score for symptoms scales=higher symptom burden. Least Square (LS) mean and Standard Error (SE) were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported in this outcome measure.
Time Frame
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23) Domain Scores
Description
QLQ-BR23: disease-specific Health-related QOL assesses breast cancer impact & side effects of treatment. EORTCQLQ- BR23 contains 23 items: multi-item scales & single-item measures. 4 functional scales (body image, sexual functioning, sexual enjoyment, future perspective) & 4 scales related to symptoms of disease or treatment (arm symptoms, breast symptoms, systemic therapy side effects, & upset by hair loss). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0-100. Higher score for functional scales=better outcome; higher score for symptoms scales=higher symptom burden. LS mean & SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value & stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain was reported.
Time Frame
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores
Description
EORTC QLQ-BR45: comprised of all 23 items from the QLQ-BR23 plus an additional 22 items assessing endocrine therapy symptoms (10 items), endocrine sexual symptoms (4 items), breast satisfaction (2 items), and skin mucosis symptoms (6 items). All items scored 1 (not at all) to 4 (very much). Scores of all scales transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. LS mean and SE are derived from Mixed Model Repeated Measures (MMRM) model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for each domain (endocrine therapy symptoms, endocrine sexual symptoms, breast satisfaction and skin mucosis symptoms) was reported.
Time Frame
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Title
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Visual Analog Scale (VAS) Score
Description
EQ-5D-5L is a standardized measure of health status, provides a simple, generic measure of health for clinical and economic appraisal, and consists of 2 sections: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L VAS. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. LS mean and SE are derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values of overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for VAS was reported in this outcome measure.
Time Frame
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Title
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health Utility Index Value Score
Description
EQ-5D-5L: consists of 2 sections: EQ-5D-5L health state utility index (descriptive system) & VAS. The EQ-5D descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, & extreme problems. Response options are measured with 5-point Likert scale (for 5L version). The EQ-5D-5L responses are converted into single index utility score between 0 to 1, where higher score indicates better health state & lower score indicate worse health state. LS mean and SE were derived from MMRM model with change from Baseline values as response variable, treatment, time, treatment-by-time interaction, Baseline value and stratifications factors as fixed effect. Average of LS mean change from Baseline values overall treatment (i.e., each cycle [Cycle 1 up to Cycle 21]) for health utility index value score was reported in this outcome measure.
Time Frame
Baseline, overall treatment duration (Cycle 1 up to Cycle 21 [i.e., 81 weeks])
Title
Time to First Chemotherapy
Description
Time to chemotherapy was defined as the time interval (in months) from the date of randomization to the start date of the first chemotherapy after disease progression.
Time Frame
From randomization to the start date of the first chemotherapy (maximum exposure duration: 81 weeks)
Title
Number of Participants With Hematological Abnormalities During the Treatment Period
Description
Hematological parameters assessed were anemia, lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, platelet count decreased. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 5.0 (NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment.
Time Frame
From first dose of study treatment up to 30 days after last dose of study treatment (maximum exposure: 81 weeks)
Title
Number of Participants With Liver Function Abnormalities of Grade 3 and 4 During the Treatment Period
Description
Liver Function parameters assessed were aspartate aminotransferase increased, alanine aminotransferase increased, alkaline phosphatase increased, total bilirubin increased, gamma-glutamyl transferase increased. Parameters were assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Treatment period was defined as the time from the first dose of study treatments up to 30 days after last dose of study treatment. Participants with Grade 3 and 4 liver function abnormalities were reported in this outcome measure.
Time Frame
From first dose of study treatment up to 30 days after last dose of study treatment (maximum exposure: 81 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment. Confirmed diagnosis of ER+/HER2- breast cancer. No prior systemic treatment for loco-regional recurrent or metastatic disease. Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Participants should be willing to provide tumor tissue. Capable of giving informed consent. Exclusion criteria: Known active brain metastases. Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD). Inadequate organ and marrow function. Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy. Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods. Male participants who disagree to follow contraception. Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term. Participants with significant concomitant illness. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :8400075
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Investigational Site Number :8400083
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Investigational Site Number :8400066
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Investigational Site Number :8400038
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Investigational Site Number :8400056
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Investigational Site Number :8400029
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Investigational Site Number :8400025
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number :8400059
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Investigational Site Number :8400053
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site Number :8400081
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Investigational Site Number :8400055
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Investigational Site Number :8400016
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Investigational Site Number :8400034
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Investigational Site Number :8400035
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Investigational Site Number :8400039
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number :8400008
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Investigational Site Number :8400006
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Investigational Site Number :8400013
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205-2003
Country
United States
Facility Name
Investigational Site Number :8400028
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Investigational Site Number :8400017
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Investigational Site Number :8400076
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Investigational Site Number :8400077
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02463
Country
United States
Facility Name
Investigational Site Number :8400002
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Investigational Site Number :8400005
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Investigational Site Number :8400004
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Site Number :8400058
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Investigational Site Number :8400015
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901-1914
Country
United States
Facility Name
Investigational Site Number :8400024
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
00000
Country
United States
Facility Name
Investigational Site Number :8400010
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Investigational Site Number :8400023
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
Facility Name
Investigational Site Number :8400009
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Investigational Site Number :8400067
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Investigational Site Number :8400001
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Investigational Site Number :8400073
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Investigational Site Number :8400072
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number :8400070
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number :8400080
City
Denton
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Investigational Site Number :8400061
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Investigational Site Number :8400068
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Investigational Site Number :8400084
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Investigational Site Number :8400086
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Investigational Site Number :8400078
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Investigational Site Number :8400082
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Investigational Site Number :8400085
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Investigational Site Number :8400069
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Investigational Site Number :0320005
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1019ABS
Country
Argentina
Facility Name
Investigational Site Number :0320008
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
Investigational Site Number :0320006
City
Pergamino
State/Province
Buenos Aires
ZIP/Postal Code
B2700CPM
Country
Argentina
Facility Name
Investigational Site Number :0320010
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Investigational Site Number :0320002
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Investigational Site Number :0320004
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Facility Name
Investigational Site Number :0320003
City
La Rioja
ZIP/Postal Code
5300
Country
Argentina
Facility Name
Investigational Site Number :0320009
City
Mar del Plata
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Investigational Site Number :0320007
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Investigational Site Number :0360004
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Investigational Site Number :0360005
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Investigational Site Number :0360003
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Investigational Site Number :0360002
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Investigational Site Number :0360001
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Investigational Site Number :0400001
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number :0560003
City
Bruxelles
ZIP/Postal Code
BE-1200
Country
Belgium
Facility Name
Investigational Site Number :0560004
City
Charleroi
ZIP/Postal Code
B-6000
Country
Belgium
Facility Name
Investigational Site Number :0560001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number :0560002
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Investigational Site Number :0760005
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035 003
Country
Brazil
Facility Name
Investigational Site Number :0760006
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Investigational Site Number :0760007
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Investigational Site Number :0760003
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Investigational Site Number :0760004
City
Rio De Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Investigational Site Number :0760008
City
São Paulo
ZIP/Postal Code
04321-120
Country
Brazil
Facility Name
Investigational Site Number :1000004
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Investigational Site Number :1000005
City
Dobrich
Country
Bulgaria
Facility Name
Investigational Site Number :1000008
City
Russe
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Facility Name
Investigational Site Number :1240004
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Investigational Site Number :1240002
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Investigational Site Number :1240007
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Investigational Site Number :1240014
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1S6
Country
Canada
Facility Name
Investigational Site Number :1240005
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Investigational Site Number :1520005
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Investigational Site Number :1520004
City
Temuco
State/Province
La Araucanía
ZIP/Postal Code
4810561
Country
Chile
Facility Name
Investigational Site Number :1520009
City
Talca
State/Province
Maule
Country
Chile
Facility Name
Investigational Site Number :1520011
City
Santaigo
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8241470
Country
Chile
Facility Name
Investigational Site Number :1520006
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7650568
Country
Chile
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Investigational Site Number :1520001
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Investigational Site Number :1520003
City
Santiago de Chile
Country
Chile
Facility Name
Investigational Site Number :1520007
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Investigational Site Number :1560038
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
Investigational Site Number :1560008
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Investigational Site Number :1560035
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number :1560003
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number :1560036
City
Changchun
ZIP/Postal Code
130041
Country
China
Facility Name
Investigational Site Number :1560013
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Investigational Site Number :1560019
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Investigational Site Number :1560031
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
Investigational Site Number :1560021
City
Dalian
ZIP/Postal Code
116027
Country
China
Facility Name
Investigational Site Number :1560054
City
Deyang
ZIP/Postal Code
618000
Country
China
Facility Name
Investigational Site Number :1560043
City
Fuzhou
ZIP/Postal Code
354200
Country
China
Facility Name
Investigational Site Number :1560025
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Investigational Site Number :1560006
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Investigational Site Number :1560007
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Investigational Site Number :1560002
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Investigational Site Number :1560005
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
Investigational Site Number :1560011
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Investigational Site Number :1560041
City
Hefei
ZIP/Postal Code
233004
Country
China
Facility Name
Investigational Site Number :1560018
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Investigational Site Number :1560046
City
Jinan
ZIP/Postal Code
250117
Country
China
Facility Name
Investigational Site Number :1560051
City
Jining
Country
China
Facility Name
Investigational Site Number :1560017
City
Linyi
ZIP/Postal Code
276000
Country
China
Facility Name
Investigational Site Number :1560055
City
Luoyang
ZIP/Postal Code
471003
Country
China
Facility Name
Investigational Site Number :1560048
City
Neijiang
ZIP/Postal Code
641003
Country
China
Facility Name
Investigational Site Number :1560001
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Investigational Site Number :1560037
City
Shaoguan
ZIP/Postal Code
512025
Country
China
Facility Name
Investigational Site Number :1560028
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Investigational Site Number :1560033
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Investigational Site Number :1560024
City
Wuhan
ZIP/Postal Code
430079
Country
China
Facility Name
Investigational Site Number :1560045
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Investigational Site Number :1560044
City
Xi'An
ZIP/Postal Code
710061
Country
China
Facility Name
Investigational Site Number :1560027
City
Xuzhou
ZIP/Postal Code
221009
Country
China
Facility Name
Investigational Site Number :1560049
City
Yantai
ZIP/Postal Code
264000
Country
China
Facility Name
Investigational Site Number :1560022
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Investigational Site Number :2030001
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
Investigational Site Number :2030002
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number :2460001
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Investigational Site Number :2460002
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Investigational Site Number :2460003
City
Turku
ZIP/Postal Code
FIN-20520
Country
Finland
Facility Name
Investigational Site Number :2500009
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Investigational Site Number :2500003
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Investigational Site Number :2500001
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Investigational Site Number :2500006
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Investigational Site Number :2500007
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Investigational Site Number :2500002
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Investigational Site Number :2500010
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
Investigational Site Number :2500005
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number :2500004
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Investigational Site Number :2680005
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Facility Name
Investigational Site Number :2680006
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
Investigational Site Number :2680001
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Investigational Site Number :2680002
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Investigational Site Number :2680004
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigational Site Number :2680007
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Investigational Site Number :2680003
City
Tbilisi
ZIP/Postal Code
0168
Country
Georgia
Facility Name
Investigational Site Number :2760006
City
Bottrop
ZIP/Postal Code
46236
Country
Germany
Facility Name
Investigational Site Number :2760003
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigational Site Number :2760007
City
Oldenburg in Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Investigational Site Number :2760001
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Investigational Site Number :3480008
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Investigational Site Number :3480011
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Investigational Site Number :3480005
City
Győr
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Investigational Site Number :3480003
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Investigational Site Number :3480009
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Investigational Site Number :3480010
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Investigational Site Number :3480001
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Investigational Site Number :3800008
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Investigational Site Number :3800003
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Investigational Site Number :3800007
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Investigational Site Number :3800010
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site Number :3800004
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigational Site Number :3800002
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Investigational Site Number :3800006
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number :3800005
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Investigational Site Number :3920016
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Investigational Site Number :3920007
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Investigational Site Number :3920002
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Investigational Site Number :3920009
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Investigational Site Number :3920019
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0013
Country
Japan
Facility Name
Investigational Site Number :3920017
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Investigational Site Number :3920010
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Investigational Site Number :3920001
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Investigational Site Number :3920012
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
Investigational Site Number :3920014
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Investigational Site Number :3920006
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Investigational Site Number :3920020
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-0803
Country
Japan
Facility Name
Investigational Site Number :3920022
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
880-8510
Country
Japan
Facility Name
Investigational Site Number :3920008
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Investigational Site Number :3920018
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Investigational Site Number :3920013
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1241
Country
Japan
Facility Name
Investigational Site Number :3920021
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Investigational Site Number :3920003
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Investigational Site Number :3920015
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Investigational Site Number :3920005
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Investigational Site Number :4100006
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100005
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100007
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100004
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100003
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100002
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
138-878
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100009
City
Seochogu
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100008
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Investigational Site Number :5280006
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Investigational Site Number :5280005
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Investigational Site Number :5280001
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Investigational Site Number :6160002
City
Tomaszow Mazowiecki
State/Province
Lódzkie
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Investigational Site Number :6160007
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Investigational Site Number :6200005
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Investigational Site Number :6200001
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number :6200002
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Investigational Site Number :6430007
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
Krasnogorskiy District
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Investigational Site Number :6430009
City
Moscow Region
ZIP/Postal Code
143442
Country
Russian Federation
Facility Name
Investigational Site Number :6430008
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
Moscow
ZIP/Postal Code
117186
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Investigational Site Number :6430006
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Saint -Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Investigational Site Number :6430010
City
Saint Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Investigational Site Number :7020002
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Investigational Site Number :7020004
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Investigational Site Number :7020001
City
Singapore
ZIP/Postal Code
329563
Country
Singapore
Facility Name
Investigational Site Number :7100004
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Investigational Site Number :7100006
City
Johannesburg
ZIP/Postal Code
1709
Country
South Africa
Facility Name
Investigational Site Number :7240011
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08017
Country
Spain
Facility Name
Investigational Site Number :7240008
City
Barcelona / Sabadell
State/Province
Castilla Y León
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Santiago de Compostela
State/Province
Galicia [Galicia]
ZIP/Postal Code
15706
Country
Spain
Facility Name
Investigational Site Number :7240006
City
Madrid / Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Madrid / Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28050
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Valencia
State/Province
Valenciana, Comunidad
ZIP/Postal Code
46010
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Investigational Site Number :7240007
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number :7240009
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Investigational Site Number :1580007
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Investigational Site Number :1580002
City
Tainan
Country
Taiwan
Facility Name
Investigational Site Number :1580001
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Investigational Site Number :1580003
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Investigational Site Number :7920006
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Investigational Site Number :7920008
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Investigational Site Number :7920009
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Investigational Site Number :7920007
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Investigational Site Number :7920005
City
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Investigational Site Number :7920013
City
Diyarbakır
ZIP/Postal Code
21100
Country
Turkey
Facility Name
Investigational Site Number :7920003
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Investigational Site Number :7920011
City
Istanbul
ZIP/Postal Code
34457
Country
Turkey
Facility Name
Investigational Site Number :7920004
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Investigational Site Number :7920012
City
Ä°zmir
ZIP/Postal Code
0000
Country
Turkey
Facility Name
Investigational Site Number :7920010
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Investigational Site Number :7920002
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Investigational Site Number :8040004
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigational Site Number :8040010
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Investigational Site Number :8040001
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Investigational Site Number :8040007
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Investigational Site Number :8260001
City
Glasgow
State/Province
Central Bedfordshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Investigational Site Number :8260002
City
Edinburgh
State/Province
Edinburgh, City Of
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Investigational Site Number :8260005
City
Blackburn
State/Province
Lancashire
ZIP/Postal Code
BB2 3HH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Citations:
PubMed Identifier
35309087
Citation
Bardia A, Cortes J, Hurvitz SA, Delaloge S, Iwata H, Shao ZM, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O'Shaughnessy J. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Mar 15;14:17588359221083956. doi: 10.1177/17588359221083956. eCollection 2022.
Results Reference
derived

Learn more about this trial

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

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