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Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

NCT05128773 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-09-16

Study results available
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Summary

This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The primary objective was to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival.

The treatment duration per participant was to be 5 years, followed with a subsequent 5-years follow-up period. For the treatment period, visits were scheduled at the start of treatment, then at 4 weeks and 12 weeks after treatment start, and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5. For the follow-up period, visits were scheduled 30 days after last treatment and then every 12 months. Three periods were planned:

* A screening period of up to 28 days,
* A treatment period of up to 5 years,
* A follow-up period of up to 5 years.

Conditions

Interventions

DRUG

Amcenestrant

tablet, oral

DRUG

Tamoxifen

tablet, oral

DRUG

Amcenestrant-matching placebo

tablet, oral

DRUG

Tamoxifen-matching placebo

tablet, oral

Sponsors & Collaborators

  • Breast International Group

    collaborator OTHER

  • Alliance Foundation Trials, LLC.

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Etienne Brain, MD PhD · Institut Curie (Saint-Cloud and Paris), 35 rue Dailly, 92210 Saint-Cloud

  • David Cameron, Professor of Oncology · University of Edinburgh Cancer Centre, institute of Genetics and Cancer, Western General Hospital, Crewe Road South, EDINBURGH EH4 2XU Scotland

  • Otto Metzger, MD · Dana-Farber Cancer Institute, 450 Brookline Avenue Yawkey 1250

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2022-10-13
Completion
2022-10-13
FDA Drug
Yes

Countries

  • Chile
  • China

Study Locations

More Related Trials

Entities

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 NCT05128773 on ClinicalTrials.gov