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

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 ID

NCT05485766

Phase

PHASE2

Sponsor

Okayama University

Status

RECRUITING

Cancer Type

Triple Negative (TNBC) Breast Cancer

Interventions

Pembrolizumab
Paclitaxel
Carboplatin
Olaparib
Definitive Surgery

Locations (sample)

Gifu, Gifu, Japan|35.42291,136.76039
Okayama, Japan|34.65,133.93333
Tokyo, Japan|35.6895,139.69171

Key Eligibility Criteria

Male/female subjects who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of invasive br…
Have histologically confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
Confirmed germline BRCA 1/2 mutated.
Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N)…

For full eligibility, visit ClinicalTrials.gov.

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