Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Public ClinicalTrials.gov record NCT04059484. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04059484
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 367 participants
Conditions and interventions
Conditions
Interventions
- Amcenestrant Drug
- Fulvestrant Drug
- Anastrozole Drug
- Letrozole Drug
- Exemestane Drug
- Tamoxifen Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2019
- Primary completion
- Feb 14, 2022
- Completion
- Jan 1, 2025
- Last update posted
- Feb 23, 2026
2019 – 2025
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology - St. Vincent's Birmingham- Site Number : 8400008 | Birmingham | Alabama | 35205 | — |
| Comprehensive Blood and Cancer Center Site Number : 8400018 | Bakersfield | California | 93309 | — |
| UCLA Santa Monica - Parkside- Site Number : 8400024 | Santa Monica | California | 90404 | — |
| University of Kansas Clinical Research Center- Site Number : 8400027 | Fairway | Kansas | 66205 | — |
| Hematology Oncology Clinic Site Number : 8400020 | Baton Rouge | Louisiana | 70809 | — |
| Dana-Farber Cancer Institute- Site Number : 8400015 | Boston | Massachusetts | 02215 | — |
| Saint Luke's Hospital of Kansas City- Site Number : 8400032 | Kansas City | Missouri | 64111 | — |
| Dartmouth-Hitchcock Medical Center - Lebanon - 1 Medical Center Drive- Site Number : 8400013 | Lebanon | New Hampshire | 03756 | — |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400025 | Hackensack | New Jersey | 07601 | — |
| Gabrail Cancer Center- Site Number : 8400006 | Canton | Ohio | 44718 | — |
| The Center for Cancer & Blood Disorders - Fort Worth- Site Number : 8400022 | Fort Worth | Texas | 76104 | — |
| University of Vermont Medical Center- Site Number : 8400026 | Burlington | Vermont | 05401 | — |
| Northwest Medical Specialties Tacoma- Site Number : 8400038 | Tacoma | Washington | 98405 | — |
| University of Wisconsin Hospitals and Clinics- Site Number : 8400016 | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04059484, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 23, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04059484 live on ClinicalTrials.gov.