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A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE)

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Trial Profile

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE)

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

Latest Information Update: 06 Mar 2024

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At a glance

  • Drugs Adavosertib (Primary) ; Ceralasertib (Primary) ; Olaparib (Primary)
  • Indications Advanced breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Therapeutic Use
  • Acronyms VIOLETTE
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 07 Sep 2023 Planned End Date changed from 29 Sep 2023 to 30 Sep 2024.
    • 06 Jun 2023 Results of an exploratory translational analysis of predictive genomic biomarkers of response to Olaparib with or without Ceralasertib beyond gBRCAm in selected biomarker subsets presented at the 59th Annual Meeting of the American Society of Clinical Oncology
    • 17 Nov 2022 Planned End Date changed from 30 Dec 2022 to 29 Sep 2023.
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