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A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency (HRD Patients With Deleterious BRCA1/2 Tumor or Germline Mutation and/or HRD Score High)

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Trial Profile

A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency (HRD Patients With Deleterious BRCA1/2 Tumor or Germline Mutation and/or HRD Score High)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Feb 2023

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At a glance

  • Drugs Olaparib (Primary) ; Carboplatin; Cyclophosphamide; Epirubicin; Paclitaxel
  • Indications Carcinoma; Early breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms GeparOla
  • Most Recent Events

    • 12 Oct 2020 Primary endpoint (response by pCR =ypT0/is ypN0) has not been met.
    • 12 Oct 2020 Results published in the Annals of Oncology.
    • 21 Sep 2020 Results (n=105) assessing germline mutation status and therapy response in patients with homologous recombination deficient, HER2-negative early breast cancer, presented at the 45th European Society for Medical Oncology Congress
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