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A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

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A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

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

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs Olaparib (Primary)
  • Indications Adenocarcinoma; Early breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OlympiA
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 08 Feb 2024 According to an AstraZeneca media release, based on results form this trial the company has submitted NDA to China's NMPA for gBRCA breast cancer (adjuvant).
    • 10 Oct 2022 Second interim results of OS with updates of IDFS, DDFS, and safety,published in the Annals of Oncology
    • 25 Aug 2022 According to a Merck & Co media release, LYNPARZA has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the adjuvant treatment for patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high recurrent risk breast cancer based on results from this trial.

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