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Spots Global Cancer Trial Database for Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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