At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Placebo, and 5 other interventions for Triple-negative Breast Cancer. Completed, enrolled 333 participants across 68 sites in 13 countries.
Detailed 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).
Study Details
Timeline
Interventions
Atezolizumab was administered as per schedule described in respective arm.
Placebo matched to atezolizumab was administered as per schedule described in respective arm.
Nab-paclitaxel was administered as per schedule described in the arms.
Doxorubicin was administered as per schedule described in the arms.
Cyclophosphamide was administered as per schedule described in the arms.
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.