Breast Cancer Clinical Trial
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
Summary
This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.
Eligibility Criteria
Inclusion Criteria:
Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer
Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (>) 2 centimeter (cm) (Stage 2)
Eastern cooperative oncology group (ECOG) performed status of 0, 1 or 2; 0 or 1 (cohort E only)
Life expectancy of 12 or more weeks
Adequate hematologic and end-organ function
Left ventricular ejection fraction greater than or equal to (>=) 50 percentage (%); >=55% (cohort E only)
Exclusion Criteria:
Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
Leptomeningeal disease
Pregnancy or lactation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
Positive test for human immunodeficiency virus (HIV)
Active hepatitis B or hepatitis C
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There are 20 Locations for this study
Birmingham Alabama, 35294, United States
Little Rock Arkansas, 72205, United States
Joliet Illinois, 60435, United States
Lafayette Indiana, 47905, United States
Baltimore Maryland, 21287, United States
Detroit Michigan, 48201, United States
Kansas City Missouri, 64132, United States
Bronx New York, 10461, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45242, United States
Bethlehem Pennsylvania, 18015, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Milwaukee Wisconsin, 53226, United States
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