NCT03197935

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody	Atezolizumab was administered as per schedule described in respective arm.
DRUG	Placebo	Placebo matched to atezolizumab was administered as per schedule described in respective arm.
DRUG	Nab-paclitaxel	Nab-paclitaxel was administered as per schedule described in the arms.
DRUG	Doxorubicin	Doxorubicin was administered as per schedule described in the arms.
DRUG	Cyclophosphamide	Cyclophosphamide was administered as per schedule described in the arms.
DRUG	Filgrastim	Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
DRUG	Pegfilgrastim	Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

Timeline

• Start date: 2017-07-24
• Primary completion: 2020-04-03
• Completion: 2022-09-28
• First posted: 2017-06-23
• Last updated: 2023-10-26
• Results posted: 2021-06-02

Locations

68 sites across 13 countries: United States, Australia, Belgium, Brazil, Canada, Germany, Italy, Japan, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study