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

Phase 1 Completed 98 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2015-12-31
Primary completion: 2019-11-13
Completion: 2019-11-13

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	840 mg	Intravenous
Subject	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Subject	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Trastuzumab emtansine	Other / unclassified	2.4 mg/kg	Intravenous
Subject	Trastuzumab emtansine	Other / unclassified	3 mg/kg	Intravenous
Subject	Trastuzumab emtansine	Other / unclassified	3.6 mg/kg	Intravenous

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

Summary

Timeline

Drugs

Indications