Phase
Condition
Breast Cancer
Cancer
Treatment
Epirubicin hydrochloride
Capecitabine
Olaparib
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 locally advanced, non-metastatic (M0), breast cancer, defined as any of thefollowing combined primary tumor (T) and regional lymph node (N) staging per currentAmerican Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3,N0-N2; or cT4a-d, N0-N2
Has centrally confirmed diagnosis of breast cancer that is triple-negative orHR-low+/HER2- breast cancer that will be treated according to the triple-negativebreast cancer (TNBC) paradigm
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has uncontrolled or significant cardiovascular disease before randomization
Has clinically significant corneal disease
Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcomaand/or multicentric Castleman disease
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, oranti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitoryT-cell receptor
Has received any prior treatment, including radiation, systemic therapy, and/ordefinitive surgery for currently diagnosed breast cancer
Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecanderivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
Has known additional malignancy that is progressing or has required active treatmentwithin the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis
Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease, or where suspectedILD/pneumonitis cannot be ruled out by standard diagnostic assessments
Has an active infection requiring systemic therapy
Has concurrent active HBV and HCV infection
Has clinically severe respiratory compromise resulting from intercurrent pulmonaryillness
Study Design
Connect with a study center
Orchard Healthcare Research Inc. ( Site 0006)
Skokie, Illinois 60077
United StatesActive - Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
Billings, Montana 59102
United StatesActive - Recruiting
Northwest Cancer Specialists (Compass Oncology) ( Site 8003)
Tigard, Oregon 97223
United StatesActive - Recruiting
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
United StatesActive - Recruiting
Texas Oncology - DFW ( Site 8000)
Dallas, Texas 75246
United StatesActive - Recruiting
Virginia Oncology Associates (VOA) ( Site 8001)
Norfolk, Virginia 23502
United StatesActive - Recruiting
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