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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)

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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Dec 2019

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At a glance

  • Drugs Adavosertib (Primary) ; Ceralasertib (Primary) ; Olaparib (Primary)
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms VIOLETTE
  • Sponsors AstraZeneca
  • Most Recent Events

    • 11 Jun 2019 Planned number of patients changed from 1100 to 1300.
    • 04 Jun 2019 The first prespecified futility analysis in Stratum C has met the recruitment target and will be assessed by unblinded review April 2019 as per trial design presented at the 55th Annual Meeting of the American Society of Clinical Oncology
    • 04 Jun 2019 Trial design presented at the 55th Annual Meeting of the American Society of Clinical Oncology
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