NCT03125902

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 653 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody	Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
DRUG	Atezolizumab Placebo	Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.
DRUG	Paclitaxel	Paclitaxel will be administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.

Timeline

• Start date: 2017-08-25
• Primary completion: 2019-11-15
• Completion: 2023-01-17
• First posted: 2017-04-24
• Last updated: 2024-03-26
• Results posted: 2021-01-07

Locations

161 sites across 24 countries: United States, Argentina, Brazil, Canada, China, Croatia, Czechia, France, Germany, Greece, India, Israel, Italy, Japan, Morocco, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study