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RECRUITING
NCT05485766
PHASE2

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

Sponsor: Okayama University

View on ClinicalTrials.gov

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

Official title: Neoadjuvant and Adjuvant Olaparib Plus Pembrolizumab Following Platinum Based Chemotherapy Plus Pembrolizumab for Germline BRCA Mutated Triple Negative Breast Cancer (WJOG14020B/OPERETTA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2024-07-16

Completion Date

2028-09-30

Last Updated

2025-03-20

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

200 mg fixed dose, IV, every 3 weeks (Q3W), on Days 1 of Cycles 1-4

DRUG

Paclitaxel

80 mg/m2, IV, weekly, on Days 1, 8, 15 of Cycles 1-4

DRUG

Carboplatin

Area under the curve (AUC 1.5), intravenously (IV), weekly, on Days 1, 8, 15 of Cycles 1-4

DRUG

Olaparib

300 mg BID (twice daily) orally

PROCEDURE

Definitive Surgery

Each subject will undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant treatment.

Locations (3)

Gifu University Hospital

Gifu, Gifu, Japan

Okayama University Hospital

Okayama, Japan

St. Luke's International Hospital

Tokyo, Japan