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
Male/female subjects who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of invasive breast cancer
Have histologically confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
Confirmed germline BRCA 1/2 mutated.
T1c, N1-N2
Subjects who has a positive urine pregnancy test within 72 hours prior to registration
Has diagnosed as inflammatory breast cancer.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor .
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.
Okayama University
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator