RecruitingPhase 2NCT05485766

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)


Sponsor

Okayama University

Enrollment

23 participants

Start Date

Jul 16, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of treatments — using a targeted therapy (olaparib) alongside and after standard chemotherapy — for people with a specific type of breast cancer called triple-negative breast cancer (TNBC) who also carry a BRCA1 or BRCA2 gene mutation. These gene mutations increase the cancer's vulnerability to certain drugs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with invasive triple-negative breast cancer (TNBC) confirmed by biopsy - You have a germline (inherited) BRCA1 or BRCA2 mutation - Your cancer has not yet spread to distant organs (non-metastatic) but is locally advanced - You have not previously received treatment for this cancer - Your general health status is good (ECOG 0–1) **You may NOT be eligible if...** - You are pregnant (confirmed by pregnancy test) - You have inflammatory breast cancer - You have received prior chemotherapy or immunotherapy for this cancer - You have significant cardiovascular or gastrointestinal problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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

DRUGPaclitaxel

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

DRUGCarboplatin

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

DRUGOlaparib

300 mg BID (twice daily) orally

PROCEDUREDefinitive 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

View Full Details on ClinicalTrials.gov

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NCT05485766


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