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Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

NCT02605915

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer

Interventions: Atezolizumab, Carboplatin, Docetaxel, Pertuzumab, Trastuzumab

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (20)

Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Joliet, Illinois, United States
Lafayette, Indiana, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Milwaukee, Wisconsin, United States