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.
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