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A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

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Trial Profile

A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2024

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At a glance

  • Drugs Amcenestrant (Primary) ; Palbociclib (Primary) ; Goserelin; Letrozole
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms AMEERA-5
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement
  • Most Recent Events

    • 11 Feb 2024 This trial has been discontinued in Portugal, According to European Clinical Trials Database record.
    • 01 Oct 2023 This trial has been completed in France according to European Clinical Trials Database record.
    • 14 Jun 2023 This trial has been completed in Belgium, Czechia and Finland (End Date: 26 May 2023), according to European Clinical Trials Database record.
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