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

Sponsor
Okayama University
Study ID
NCT05485766
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    200 mg fixed dose, IV, every 3 weeks (Q3W), on Days 1 of Cycles 1-4
  • Paclitaxel — DRUG
    80 mg/m2, IV, weekly, on Days 1, 8, 15 of Cycles 1-4
  • Carboplatin — DRUG
    Area under the curve (AUC 1.5), intravenously (IV), weekly, on Days 1, 8, 15 of Cycles 1-4
  • Olaparib — DRUG
    300 mg BID (twice daily) orally
  • Definitive Surgery — PROCEDURE
    Each subject will undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant treatment.

Study Details

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

Key Dates

Start date
Jul 16, 2024
Status verified
Jan 2025
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab+ Paclitaxel + Carboplatin Followed by Pembrolizumab + Olaparib
    1. Neoadjuvant phase; Treatment 1: Pembrolizumab+ Paclitaxel + Carboplatin (Cycles 1-4) Treatment 2: Pembrolizumab + Olaparib (Cycles 1-4) 2. Definitive Surgery 3. Adjuvant phase; Pembrolizumab + Olaparib (1-9 cycles) Note: each cycle = 3 weeks (Neoadjuvant Treatment 1 and 2, and Adjuvant Treatment)

Primary Outcome Measure

Pathological Complete Response (pCR) Rate (ypT0/TisypN0) [ Time Frame: From 27 weeks up to 30 weeks ]

Central Contacts

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