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

NCT04059484 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2026-02-24

Study results available
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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

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Amcenestrant

Pharmaceutical form: Capsule Route of administration: Oral

DRUG

Fulvestrant

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

DRUG

Anastrozole

Pharmaceutical form:Tablets or capsules Route of administration: Oral

DRUG

Letrozole

Pharmaceutical form: Tablets or capsules Route of administration: Oral

DRUG

Exemestane

Pharmaceutical form: Tablets or capsules Route of administration: Oral

DRUG

Tamoxifen

Pharmaceutical form: Tablets or capsules Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2022-02-15
Completion
2025-01-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Greece
  • Israel
  • Italy
  • Japan
  • Latvia
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04059484 on ClinicalTrials.gov