NCT04584112

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

A Phase Ib, Open-Label, Multicohort Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Patients With Triple-Negative Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Tiragolumab	Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.
DRUG	Atezolizumab	Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.
DRUG	Nab-paclitaxel	Nab-paclitaxel 100 milligrams per square meter (mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
DRUG	Tiragolumab	Tiragolumab 420 mg administered by IV infusion Q2W.
DRUG	Atezolizumab	Atezolizumab 840 mg administered by IV infusion Q2W.
DRUG	Nab-paclitaxel	Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.
DRUG	Carboplatin	Carboplatin (area under the concentration-time curve \[AUC\]: 5 milligrams per milliliter per minute \[mg/mL/min\]) administered by IV infusion Q3W.
DRUG	Doxorubicin	Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
DRUG	Cyclophosphamide	Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
DRUG	Granulocyte colony-stimulating factor (G-CSF)	G-CSF support for four doses.
DRUG	Granulocyte-macrophage colony-stimulating factor (GM-CSF)	GM-CSF support for four doses.

Timeline

• Start date: 2020-09-28
• Primary completion: 2023-03-08
• Completion: 2023-03-08
• First posted: 2020-10-12
• Last updated: 2023-03-15

Locations

24 sites across 8 countries: United States, Australia, Brazil, Germany, Russia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study