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

PHASE2RecruitingINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

July 16, 2024

Primary Completion Date

June 30, 2028

Study Completion Date

September 30, 2028

Conditions
Triple Negative Breast NeoplasmsTriple Negative Breast CancerBreast NeoplasmsBreast CancerBRCA1 MutationBRCA2 MutationBRCA MutationBRCA-Associated Breast Carcinoma
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.

Trial Locations (3)

5011194

RECRUITING

Gifu University Hospital, Gifu

Unknown

RECRUITING

Okayama University Hospital, Okayama

RECRUITING

St. Luke's International Hospital, Tokyo

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Okayama University

OTHER