NCT05485766

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Okayama University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Triple Negative Breast Neoplasms
• Triple Negative Breast Cancer
• Breast Neoplasms
• Breast Cancer
• BRCA1 Mutation
• BRCA2 Mutation
• BRCA Mutation
• BRCA-Associated Breast Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-16
• Primary completion: 2028-06-30
• Completion: 2028-09-30
• First posted: 2022-08-03
• Last updated: 2025-03-20

Locations

3 sites across 1 country: Japan