Actively Recruiting
Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer
Led by Okayama University · Updated on 2025-03-20
23
Participants Needed
3
Research Sites
219 weeks
Total Duration
On this page
Sponsors
O
Okayama University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older with confirmed invasive breast cancer
- Histologically confirmed triple negative breast cancer per ASCO/CAP guidelines
- Confirmed germline BRCA 1/2 mutation
- Untreated locally advanced non-metastatic TNBC with specific tumor and lymph node staging (T1c N1-N2, T2 N0-N2, T3 N0-N2, T4a-d N0-N2)
- No distant metastasis confirmed by chest, abdominal, bone imaging; brain imaging if symptoms present
- Written informed consent provided
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function confirmed within 10 days before treatment start
You will not qualify if you...
- Positive urine pregnancy test within 72 hours before registration
- Diagnosis of inflammatory breast cancer
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or other T-cell receptor targeted agents
- Receipt of live or live-attenuated vaccine within 30 days before first study dose
- Participation in another investigational study or use of investigational device within 4 weeks before first study dose
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days before first study dose
- History of second malignancy unless treated curatively with no evidence for 2 years
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab, study drugs, or excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of non-infectious pneumonitis or interstitial lung disease
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis B or Hepatitis C infection
- Known active tuberculosis
- History or current serious medical conditions or laboratory abnormalities interfering with study
- Psychiatric or substance abuse disorders interfering with study compliance
- Pregnant, breastfeeding, or planning to conceive/father children
- Prior allogenic tissue or solid organ transplant
- Previous treatment with Olaparib or other PARP inhibitors
- Significant cardiovascular disease or uncontrolled cardiac conditions
- Myelodysplastic syndrome or acute myeloid leukemia
- Use of colony-stimulating factors within 28 days before first study dose
- Poor medical risk due to serious uncontrolled disorders or infections
- Inability to swallow oral medication or gastrointestinal absorption issues
- Unlikely to comply with study procedures or restrictions
- Current use of strong or moderate CYP3A4 inhibitors or inducers that cannot be stopped during study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Gifu University Hospital
Gifu, Gifu, Japan, 5011194
Actively Recruiting
2
Okayama University Hospital
Okayama, Japan
Actively Recruiting
3
St. Luke's International Hospital
Tokyo, Japan
Actively Recruiting
Research Team
Y
Yuko Takahashi, MD., PhD.
CONTACT
H
Hironobu TAN, PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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