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Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3)

Primary Purpose

Breast Cancer Metastatic

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Amcenestrant

Fulvestrant

Anastrozole

Letrozole

Exemestane

Tamoxifen

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic

Eligibility Criteria

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

Inclusion criteria :

18 years or older.
Histological or cytological diagnosis of adenocarcinoma of the breast.
Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
ER positive status.
HER2 negative status.
Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
In the main study, a prior treatment with a CDK 4/6 inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor.
Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy.
Male or Female.

Exclusion criteria:

Eastern Cooperative Oncology Group performance status ≥2.
Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant. Participants unable to swallow normally and to take capsules.
Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed.
Severe uncontrolled systemic disease at screening .
Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader (SERD) compound, except fulvestrant if stopped for at least 3 months before randomization.
Treatment with drugs that have the potential to inhibit UGT less than 2 weeks before randomization.
Treatment with strong CYP3A inducers within 2 weeks before randomization.
Ongoing treatment with drugs that are sensitive substrate of organic anion transporting polypeptide 1B1/B3 (OATP1B1/B3) (asunaprevir, atorvastatin, bosentan, danoprevir, fexofenadine, glyburide, nateglinide, pitavastatin, pravastatin, replaglinide, rosuvastatin, and simvastatin acid).
Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
Inadequate hematological, coagulation, renal and liver functions.

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amcenestrant

Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator

Arm Description

Daily amcenestrant dose administered orally under fed or fast condition

Control treatment of the choice of the physician depending on each participant's medical condition and in accordance with the approved label may include 1 of the following treatments used as monotherapy. Fulvestrant Aromatase inhibitors (anastrozole, letrozole, exemestane) Selective estrogen receptor modulator (Tamoxifen)

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS is defined as the time in months interval 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 independent central review (ICR) 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 is defined as the time interval 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 is known to be alive or at the cut-off date, whichever comes first. Analysis was performed by Kaplan-Meier method.

Percentage of Participants With Objective Response

Objective response is defined as percentage of participants having a partial response (PR) or complete response (CR) according to the RECIST version 1.1 assessed by ICR. 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.

Percentage of Participants With Disease Control

Disease control is defined as percentage of participants having a confirmed CR, PR, or stable disease (SD) or Non-CR/Non-PD as BOR determined by ICR as per RECIST 1.1 from the date of randomization to the date of end of treatment. As per RECIST 1.1, CR: 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 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 progressive disease (PD), taking as reference the smallest sum diameters. Non-CR/Non-PD: persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.

Percentage of Participants With Clinical Benefit

Clinical Benefit is defined as percentage of participants having a confirmed CR, PR, SD, or Non-CR/Non-PD for at least 24 weeks determined by ICR as per RECIST 1.1 from the date of randomization to the date of end of treatment. As per RECIST 1.1, CR: 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. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Non-CR/Non-PD: persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions.

Duration of Response (DOR)

DOR is defined as time (in months) from first documented evidence of CR or PR until progressive disease (PD) determined by ICR as per RECIST 1.1 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: 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.

Progression Free Survival (PFS) According to Estrogen Receptor 1 Gene (ESR1) Mutation Status

PFS defined as the time (in months) interval from the date of randomization to the date of first documented tumor progression as per RECIST 1.1 assessed by ICR or death (due to any cause), whichever comes first. Progression 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. The mutation status (wild type, mutant) of twelve specific mutations of the ESR1 gene was determined by multiplex droplet digital polymerase chain reaction (ddPCR), including their mutant frequency and concentration. Here, PFS is reported based on the ESR1 mutation status of participants: wild type and mutants. ESR1 was the gene encoding estrogen receptor alpha. ESR1 mutant type breast cancer was a disease where the ESR1 gene had a mutation (i.e., a type of error). ESR1 wild type breast cancer was a disease where the ESR1 gene was normal without a mutation. Analysis was performed by Kaplan-Meier method.

Pharmacokinetics: Plasma Concentrations of Amcenestrant

Amcenestrant plasma concentrations at specified time points are reported.

Within-Participant Steady State Ctrough of Amcenestrant

Within-participant Steady state Ctrough was defined as the median value of the Ctrough across study using plasma concentration of predose samples at Cycle 1 Day 15 and Day 1 of Cycle 2, 3, 4 and 6 for each individual participant. Average (mean) of all calculated Ctrough values for all participants across study (Cycle 1 Day 15 and Day 1 of Cycle 2, 3, 4 and 6 ) was derived and reported in this outcome measure.

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) and 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) 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 30]) 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: 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 30]) 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

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 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 overall treatment (i.e., each cycle [Cycle 1 up to Cycle 30]) 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 impact of breast cancer & side effects of treatment. EORTC-QLQ-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 to 100. Higher score for functional scales = better outcome; higher score for symptoms scales = higher symptom burden. 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 30]) was reported.

Full Information

NCT ID

NCT04059484

First Posted

August 9, 2019

Last Updated

September 22, 2023

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04059484

Brief Title

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

Acronym

AMEERA-3

Official Title

An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 22, 2019 (Actual)

Primary Completion Date

February 15, 2022 (Actual)

Study Completion Date

December 29, 2023 (Anticipated)

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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: To compare the overall survival in the 2 treatment arms To assess the objective response rate in the 2 treatment arms To evaluate the disease control rate in the 2 treatment arms To evaluate the clinical benefit rate in the 2 treatment arms To evaluate the duration of response in the 2 treatment arms To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms To evaluate the pharmacokinetics of amcenestrant as single agent To evaluate health-related quality of life in the 2 treatment arms To compare the overall safety profile in the 2 treatment arms

Detailed Description

The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days of study treatment), and an end of treatment (EOT) visit at least 30 days (or until the participant receive another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, death or upon participant's request to stop treatment, or Investigator decision, whichever occurs first. An extension of recruitment for Chinese participants is planned in this study: After completion of randomization in the global part of the study, randomization will continue in China until approximately 90 Chinese participants are randomized.

6. Conditions and Keywords

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

Breast Cancer Metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amcenestrant

Arm Type

Experimental

Arm Description

Daily amcenestrant dose administered orally under fed or fast condition

Arm Title

Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Amcenestrant

Intervention Description

Pharmaceutical form: Capsule Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Fulvestrant

Other Intervention Name(s)

Faslodex®

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Intervention Type

Drug

Intervention Name(s)

Anastrozole

Other Intervention Name(s)

Arimidex®/Anastrozole Generics

Intervention Description

Pharmaceutical form:Tablets or capsules Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Letrozole

Other Intervention Name(s)

Femara®/Letrozole Generics

Intervention Description

Pharmaceutical form: Tablets or capsules Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Exemestane

Other Intervention Name(s)

Aromasin®/Exemestane Generics

Intervention Description

Pharmaceutical form: Tablets or capsules Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Tamoxifen

Other Intervention Name(s)

Nolvadex®/Tamoxifen Generics

Intervention Description

Pharmaceutical form: Tablets or capsules Route of administration: Oral

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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 duration: 116 weeks)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From randomization to the death due to any cause or data cut-off date whichever comes first (maximum duration: 116 weeks)

Title

Percentage of Participants With Objective Response

Description

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 duration: 116 weeks)

Title

Percentage of Participants With Disease Control

Description

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 duration: 116 weeks)

Title

Percentage of Participants With Clinical Benefit

Description

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 duration: 116 weeks)

Title

Duration of Response (DOR)

Description

Time Frame

From the date of first response to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (maximum duration: 116 weeks)

Title

Progression Free Survival (PFS) According to Estrogen Receptor 1 Gene (ESR1) Mutation Status

Description

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 duration: 116 weeks)

Title

Pharmacokinetics: Plasma Concentrations of Amcenestrant

Description

Amcenestrant plasma concentrations at specified time points are reported.

Time Frame

Cycle 1 Day 1: 1.5 hours(h), 4h post-dose, Day 15: pre-dose, Cycle 2 Day 1: pre-dose, 1.5h, 4h, 8h post-dose, Cycle 3 Day 1: pre-dose, Cycle 4 Day 1: pre-dose, Cycle 6 Day 1: pre-dose

Title

Within-Participant Steady State Ctrough of Amcenestrant

Description

Time Frame

Predose on Cycle 1 Day 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 6 Day 1

Title

Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores

Description

Time Frame

Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 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

Time Frame

Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 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

Description

Time Frame

Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 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

Time Frame

Baseline, overall treatment duration (Cycle 1 up to Cycle 30 [i.e.,116 weeks])

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : 18 years or older. Histological or cytological diagnosis of adenocarcinoma of the breast. Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease. Estrogen receptor(ER) positive status. Human epidermal growth factor receptor 2 negative status. Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease. In the main study, a prior treatment with a Cyclin-dependent kinase 4 and 6(CDK 4/6) inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor. Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy. Male or Female. Exclusion criteria: Eastern Cooperative Oncology Group performance status =>2. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant. Participants unable to swallow normally and to take capsules. Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for greater than 3 years are allowed. Severe uncontrolled systemic disease at screening . Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms. Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader(SERD) compound, except fulvestrant if stopped for at least 3 months before randomization. Treatment with drugs that have the potential to inhibit Uridine'5 Diphospho-Glucuronosyl Transferase(UGT) less than 2 weeks before randomization. Treatment with strong Cytochrome P450 (CYP)3A inducers within 2 weeks before randomization. Ongoing treatment with drugs that are sensitive substrate of organic anion transporting polypeptide 1B1/B3(OATP1B1/B3) (asunaprevir, atorvastatin, bosentan, danoprevir, fexofenadine, glyburide, nateglinide, pitavastatin, pravastatin, replaglinide, rosuvastatin, and simvastatin acid). Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization. Inadequate hematological, coagulation, renal and liver functions. The above information is not intended to contain all considerations relevant to a patient'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 :8400008

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number :8400018

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Investigational Site Number :8400024

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Investigational Site Number :8400027

City

Fairway

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Investigational Site Number :8400020

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Investigational Site Number :8400015

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Investigational Site Number :8400032

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Investigational Site Number :8400013

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Investigational Site Number :8400025

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Investigational Site Number :8400006

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Investigational Site Number :8400022

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Investigational Site Number :8400026

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Investigational Site Number :8400038

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Investigational Site Number :8400016

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Investigational Site Number :0320007

City

Buenos Aires

ZIP/Postal Code

1012

Country

Argentina

Facility Name

Investigational Site Number :0320001

City

Buenos Aires

ZIP/Postal Code

1426ANZ

Country

Argentina

Facility Name

Investigational Site Number :0320008

City

Buenos Aires

ZIP/Postal Code

C1019ABS

Country

Argentina

Facility Name

Investigational Site Number :0320006

City

Buenos Aires

ZIP/Postal Code

C1125ABD

Country

Argentina

Facility Name

Investigational Site Number :0320004

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

Investigational Site Number :0320005

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Investigational Site Number :0320002

City

Salta

ZIP/Postal Code

4400

Country

Argentina

Facility Name

Investigational Site Number :0360003

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

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 :0360002

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Investigational Site Number :0560002

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 :0560003

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Investigational Site Number :0760003

City

Sao Jose do Rio Preto

State/Province

São Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Investigational Site Number :0760005

City

Goiania

ZIP/Postal Code

74605-070

Country

Brazil

Facility Name

Investigational Site Number :0760001

City

Porto Alegre

ZIP/Postal Code

90035 003

Country

Brazil

Facility Name

Investigational Site Number :0760002

City

Porto Alegre

ZIP/Postal Code

90110-270

Country

Brazil

Facility Name

Investigational Site Number :0760006

City

Sao Paulo

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Investigational Site Number :1240004

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Investigational Site Number :1240003

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Investigational Site Number :1240006

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Investigational Site Number :1560015

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

Investigational Site Number :1560023

City

Hangzhou

ZIP/Postal Code

310016

Country

China

Facility Name

Investigational Site Number :1560002

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Investigational Site Number :1560005

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Investigational Site Number :1560013

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Investigational Site Number :1560016

City

Wuhan

ZIP/Postal Code

430079

Country

China

Facility Name

Investigational Site Number :2030002

City

Brno

ZIP/Postal Code

65653

Country

Czechia

Facility Name

Investigational Site Number :2030003

City

Novy Jicin

ZIP/Postal Code

741 01

Country

Czechia

Facility Name

Investigational Site Number :2030004

City

Praha 4

ZIP/Postal Code

14059

Country

Czechia

Facility Name

Investigational Site Number :2500008

City

Angers

ZIP/Postal Code

49055

Country

France

Facility Name

Investigational Site Number :2500006

City

Creteil

ZIP/Postal Code

94000

Country

France

Facility Name

Investigational Site Number :2500007

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Investigational Site Number :2500005

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Investigational Site Number :2500001

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Investigational Site Number :3000001

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Investigational Site Number :3000002

City

Larissa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Investigational Site Number :3000004

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

Investigational Site Number :3760002

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Investigational Site Number :3760001

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Investigational Site Number :3760003

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Investigational Site Number :3760004

City

Tel HaShomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Investigational Site Number :3800001

City

Candiolo

State/Province

Torino

ZIP/Postal Code

10060

Country

Italy

Facility Name

Investigational Site Number :3800002

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Investigational Site Number :3800003

City

Prato

ZIP/Postal Code

59100

Country

Italy

Facility Name

Investigational Site Number :3920002

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Investigational Site Number :3920001

City

Kashiwa-shi

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Investigational Site Number :3920009

City

Ota-shi

State/Province

Gunma

ZIP/Postal Code

373-8550

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 :3920005

City

Kitaadachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

Investigational Site Number :3920004

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Investigational Site Number :3920008

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Investigational Site Number :3920003

City

Osaka-shi

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

Investigational Site Number :4100001

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Investigational Site Number :4100004

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Investigational Site Number :4100003

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Investigational Site Number :4100002

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Investigational Site Number :4280002

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Investigational Site Number :4280001

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Investigational Site Number :4840005

City

Mexico

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Investigational Site Number :4840002

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number :4840006

City

Veracruz

ZIP/Postal Code

91910

Country

Mexico

Facility Name

Investigational Site Number :6160003

City

Poznan

ZIP/Postal Code

61-866

Country

Poland

Facility Name

Investigational Site Number :6160001

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Investigational Site Number :8400028

City

Ponce De Leon

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

Investigational Site Number :6430003

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Investigational Site Number :6430005

City

Moscow

ZIP/Postal Code

129090

Country

Russian Federation

Facility Name

Investigational Site Number :6430002

City

Saint -Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Investigational Site Number :7240006

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number :7240003

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number :7240001

City

Hospitalet de Llobregat

ZIP/Postal Code

08908

Country

Spain

Facility Name

Investigational Site Number :7240008

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number :1580002

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Investigational Site Number :1580003

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Investigational Site Number :1580001

City

Taipei

ZIP/Postal Code

10018

Country

Taiwan

Facility Name

Investigational Site Number :1580005

City

Taipei

ZIP/Postal Code

104

Country

Taiwan

Facility Name

Investigational Site Number :1580004

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Investigational Site Number :7920004

City

Ankara

ZIP/Postal Code

06200

Country

Turkey

Facility Name

Investigational Site Number :7920002

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Investigational Site Number :7920003

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Investigational Site Number :8040001

City

Kryvyi Rih

ZIP/Postal Code

50048

Country

Ukraine

Facility Name

Investigational Site Number :8040004

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Investigational Site Number :8040005

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

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

Learn more about this trial

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

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Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3)

Breast Cancer Metastatic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial