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A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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Trial Profile

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Jun 2024

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At a glance

  • Drugs Giredestrant (Primary) ; Letrozole; LHRH receptor agonists; Palbociclib
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms persevERA Breast Cancer
  • Sponsors Roche
  • Most Recent Events

    • 25 May 2023 Planned primary completion date changed from 26 Apr 2024 to 31 Mar 2025.
    • 13 Apr 2023 Status changed from recruiting to active, no longer recruiting.
    • 08 Jun 2021 Trial design presented at the 57th Annual Meeting of the American Society of Clinical Oncology
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