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

NCT05485766 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-03-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Yuko Takahashi, MD., PhD. · Assistant Professor, Endocrinological Center, Okayama University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485766 on ClinicalTrials.gov