drugset
drugset / Trial / NCT05485766

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

NCT05485766 ↗

Phase 2 Recruiting 23 enrolled Okayama University Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2024-07-16
Primary completion
2028-06-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Olaparib Small molecule 300 mg Oral
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications

BRCA1-related cancer predisposition BRCA2-related cancer predisposition hereditary breast carcinoma triple-negative breast carcinoma