A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

Phase 1 Completed 83 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).

Timeline

Start: 2020-09-28
Primary completion: 2023-03-08
Completion: 2023-03-08

Publications

Kuemmel S, Jung KH, Andrade L, Assad-Suzuki D, de la Cruz Merino L, Freitas-Junior R, Hegg R, Huang CS, Martin H, Schneeweiss A, Dieterich M, Nguyen Duc A, Feng Y, Meng R, Swat A, Seiller A, Bermejo B, Hamilton EP. Safety and efficacy of tiragolumab, atezolizumab and chemotherapy for early-stage or PD-L1-positive advanced triple-negative breast cancer: a phase Ib study. ESMO Open. 2025 Dec;10(12):105869. doi: 10.1016/j.esmoop.2025.105869. Epub 2025 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atezolizumab	Monoclonal antibody	840 mg	Intravenous
Subject	Atezolizumab	Monoclonal antibody	1680 mg	Intravenous
Subject	Carboplatin	Small molecule	5 unknown	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	125 mg/m2	Intravenous
Subject	Tiragolumab	Monoclonal antibody	420 mg	Intravenous
Subject	Tiragolumab	Monoclonal antibody	840 mg	Intravenous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	—	—
Background	filgrastim	Protein / enzyme biologic	—	—

A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

Summary

Timeline

Publications

Drugs

Indications