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

Recruiting Phase 2 Interventional Study
Triple Negative Breast Neoplasms Triple Negative Breast Cancer Breast Neoplasms Breast Cancer BRCA1 Mutation BRCA2 Mutation BRCA Mutation BRCA-Associated Breast Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
23 (estimated)
Sponsor
Okayama University · Other
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About This Trial
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) …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male/female subjects who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of invasive breast cancer * Have histologically confirmed TNBC, as defined by the most recent ASCO/CAP guidelines. * Confirmed germline BRCA 1/2…
Contacts

Yuko Takahashi, MD., PhD.

+81-86-223-7151

yukotaka@okayama-u.ac.jp

CONTACT

Hironobu TAN, PhD.

+81-86-235-7994

hironobu_tan@okayama-u.ac.jp

CONTACT