A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations

Trial Profile

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs Olaparib (Primary) ; Capecitabine; Eribulin; Vinorelbine
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OlympiAD
  • Sponsors AstraZeneca
  • Most Recent Events

    • 30 Nov 2017 According to a Merck AG media release, additional results from this trial as well as a subgroup analysis in Asian patients will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).
    • 23 Oct 2017 According to a Merck AG media release, based on the data from this study, the company has submitted a new drug application (NDA) to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the use of LYNPARZA (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.
    • 18 Oct 2017 According to a Myriad Genetics media release, the U.S. Food and Drug Administration (FDA) has accepted its supplementary premarket approval (sPMA) application for BRACAnalysis CDx to be used as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza (olaparib) in patients with HER2-negative metastatic breast cancer. Myriad's sPMA filing follows positive results from this study.
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