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COMPLETEDPhase 1NCT02605915

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

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 per...

Lead sponsor: Hoffmann-La Roche•20 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Hoffmann-La Roche

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 5, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment98

Start dateDec 2015

Last updatedFeb 5, 2020

Condition

HER2-Positive Metastatic Breast Cancer HER2-Negative Metastatic Breast Cancer Locally Advanced or Early Breast Cancer

Locations shown

University of Alabama at Birmingham

Birmingham, Alabama

University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute

Little Rock, Arkansas

Joliet oncology hematology associates

Joliet, Illinois

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2020Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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