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Brief Title: Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
Official Title: A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive Breast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer
Study ID: NCT02605915
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock, Arkansas, United States
Joliet oncology hematology associates, Joliet, Illinois, United States
Horizon Oncology Research, Inc., Lafayette, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Karmanos Cancer Center; Department of Oncology, Detroit, Michigan, United States
HCA Midwest Division, Kansas City, Missouri, United States
Montefiore Medical Center, Advanced Women's Health Center, Clinical Trials and Research Unit; Depart, Bronx, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke Cancer Center, Durham, North Carolina, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
St. Luke's University Health Network, Bethlehem, Pennsylvania, United States
Kimmel Cancer Center Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street, Chattanooga, Tennessee, United States
West Clinic, Germantown, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Cancer Therapy and Research Center CTRC at UTHSCSA, San Antonio, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR