Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
Completed · Phase 1
Conditions studied: HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02605915
- Run by
- Hoffmann-La Roche
- People needed
- 98
- Starts
- 2015-12-31
- Expected to finish
- 2019-11-13
- Last updated by the study team
- 2020-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- 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 — The 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
Full record on ClinicalTrials.gov
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