Study of Olaparib Plus Pembrolizumab After Platinum Chemotherapy and Pembrolizumab for Germline BRCA 12 Mutated Triple Negative Breast Cancer

What this Trial Is About

Researchers are evaluating a new treatment approach for adults with germline BRCA 1 or 2 mutated triple negative breast cancer TNBC who have not previously been treated. This Phase II, open-label trial studies the effects of combining Olaparib and Pembrolizumab after initial platinum-based chemotherapy with Pembrolizumab as a neoadjuvant therapy before surgery. The study aims to assess the pathological complete response rate and other survival outcomes in this patient group. The treatment plan includes two neoadjuvant phases first, patients receive Pembrolizumab combined with Paclitaxel and Carboplatin for four cycles, each lasting three weeks. This is followed by four cycles of Pembrolizumab combined with Olaparib. After these treatments, patients undergo definitive surgery 3 to 6 weeks later. Then, in the adjuvant phase, patients receive Pembrolizumab plus Olaparib for up to nine additional cycles, each cycle lasting three weeks. Participants will be closely monitored throughout the study with assessments including pathological evaluations to measure complete response at 27 to 30 weeks after treatment start. Researchers will track survival rates, cancer recurrence, and safety outcomes including adverse events for up to three years. The study involves regular intravenous drug administration, oral medication, and surgery, with careful follow-up to evaluate treatment effects and patient health over time.

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