OncoMatch/Clinical Trials/NCT05485766
Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer
Is NCT05485766 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Paclitaxel for triple negative breast neoplasms.
Treatment: Pembrolizumab · Paclitaxel · Carboplatin · Olaparib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: BRCA1 germline mutation
Required: BRCA2 germline mutation
Disease stage
Required: Stage T1CN1, T1CN2, T2N0, T2N1, T2N2, T3N0, T3N1, T3N2, T4AN0, T4AN1, T4AN2, T4BN0, T4BN1, T4BN2, T4CN0, T4CN1, T4CN2, T4DN0, T4DN1, T4DN2 (AJCC v7)
previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per AJCC for breast cancer staging criteria version 7
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
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
Cannot have received: PARP inhibitor (olaparib)
Has received pre-treatment with Olaparib or other PARP inhibitors.
Lab requirements
Blood counts
Have adequate organ function as defined in the protocol.
Kidney function
Have adequate organ function as defined in the protocol.
Liver function
Have adequate organ function as defined in the protocol.
Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of study treatment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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