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Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

NCT04191382 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-09-18

Study results available
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Summary

Primary Objective:

To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole.

Secondary Objectives:

* To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (\>=) 50 percent (%) (Ki67 \>=50%) in the three treatment arms.
* To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms.
* To assess safety in the three treatment arms.

Conditions

Interventions

DRUG

Amcenestrant (SAR439859)

Pharmaceutical form: Capsules, Route of administration: Oral

DRUG

Letrozole

Pharmaceutical form: Tablets, 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
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2021-04-30
Completion
2021-05-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Japan
  • Puerto Rico
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04191382 on ClinicalTrials.gov