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A Randomized, Multicenter, Double-blind, Phase 3 Study of Amcenestrant (SAR439859) Versus Tamoxifen for the Treatment of Patients With Hormone Receptor-positive, Human Epidermal Growth Factor 2-negative or Positive, Stage IIB-III Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

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Trial Profile

A Randomized, Multicenter, Double-blind, Phase 3 Study of Amcenestrant (SAR439859) Versus Tamoxifen for the Treatment of Patients With Hormone Receptor-positive, Human Epidermal Growth Factor 2-negative or Positive, Stage IIB-III Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 02 Oct 2024

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At a glance

  • Drugs Amcenestrant (Primary) ; Tamoxifen
  • Indications Adenocarcinoma; Advanced breast cancer; Early breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms AMEERA-6
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

Most Recent Events

  • 11 Feb 2024 This study has been Discontinued in Portugal, According to European Clinical Trials Database record.
  • 10 Dec 2022 Trial design presented at the 45th Annual San Antonio Breast Cancer Symposium
  • 27 Oct 2022 According to European Clinical Trials Database record the study has been prematurely ended in Hungary, Estonia, Belgium, and Denmark.

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