Phase
Condition
N/ATreatment
Olaparib (if approved/available locally)
Carboplatin
Capecitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stageN0-2
Has provided a core needle biopsy for tissue diagnosis of the current breast cancerless than 29 days prior to the date of informed consent
Has centrally confirmed diagnosis of BC that is triple-negative based on theAmerican Society of Clinical Oncology/College of American Pathologists guidelines
Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
Has left ventricle ejection fraction of ≥50% as assessed by echocardiogram ormultigated acquisition scan performed at screening
Has a history of exposure to anthracycline; participants can be eligible aftercompletion of a Sponsor consultation form, if cumulative lifetime doses are asfollows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2,Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than oneanthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has documented Grade ≥2 peripheral neuropathy
Has uncontrolled or significant cardiovascular disease
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1),anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with anagent directed to another stimulatory or coinhibitory T-cell receptor (e.g.,cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster ofdifferentiation (CD) 134], or CD137)
Has received any prior treatment, including radiation, systemic therapy, and/ordefinitive surgery for currently diagnosed breast cancer
Has received prior systemic anticancer therapy
Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodedissection prior to study treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive therapy within 7 days prior to the first doseof study intervention
Has a known additional malignancy that is progressing or has required activetreatment within the past 5 years
Has active autoimmune disease that has required systemic treatment in the past 2years with need for disease modifying agents such as corticosteroids orimmunosuppressive drugs
Has history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease
Has severe hypersensitivity (Grade ≥3) to pembrolizumab, any investigational agentor study intervention, any of its excipients, and/or to another biologic therapy
Has a history of allogeneic tissue/solid organ transplant
Study Design
Study Description
Connect with a study center
National Cheng Kung University Hospital ( Site 0901)
Tainan, 704
TaiwanSite Not Available
National Cheng Kung University Hospital ( Site 0901)
Tainan 1668355, 704
TaiwanSite Not Available
Optum Care Cancer Center ( Site 0004)
Las Vegas, Nevada 89102
United StatesSite Not Available
Optum Care Cancer Center ( Site 0004)
Las Vegas 5506956, Nevada 5509151 89102
United StatesSite Not Available

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