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Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Sep 30, 2025 to Jun 30, 2028
    • Start date changed from estimate of Feb 29, 2024 to Jul 16, 2024
    • Study completion date: Sep 30, 2027 to Sep 30, 2028
    • Study sites revised (3)
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 1, 2022 to Feb 29, 2024
    • Study sites: 0 to 3
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast cancer (TNBC). Pembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied
Trial Details
NCT Number NCT05485766
Lead Sponsor Okayama University
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Triple Negative Breast Neoplasms, Triple Negative Breast Cancer, Breast Neoplasms, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, BRCA Mutation, BRCA-Associated Breast Carcinoma
Related terms Breast Neoplasms, Fanconi Anemia, Complementation Group D1, Triple Negative Breast Neoplasms
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov