atezolizumab plus nab-paclitaxel (n=451) vs. Standard of Care (SoC) (n=451)
randomized controlled trial
atezolizumab plus nab-paclitaxel
atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
placebo plus nab-paclitaxel
placebo, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
Dose reductions of atezolizumab or placebo were not permitted; No crossover is allowed.
mBC - TNBC - L1 - all population
double blind
246 academic centres and community oncology practices in 41 countries
P3/ two sided and two interim analysis. Repartition between coprimary endpoints, and hierarchy for OS (ITT then PDL1)
Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patientswith metastatic triple-negative breast cancer in both the intention-to-treat populationand the PD-L1–positive subgroup.
IMpassion-130 (PDL1>1%), 2018 NCT02425891
atezolizumab plus nab-paclitaxel (n=185) vs. Standard of Care (SoC) (n=184)
randomized controlled trial
atezolizumab plus nab-paclitaxel
atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
placebo plus nab-paclitaxel
placebo, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
Dose reductions of atezolizumab or placebo were not permitted;No crossover is allowed.
mBC - TNBC - L1 - PDL1 positive
double blind
246 academic centres and community oncology practices in 41 countries
P3/ two sided and two interim analysis. Repartition between coprimary endpoints, and hierarchy for OS (ITT then PDL1)
Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patientswith metastatic triple-negative breast cancer in both the intention-to-treat populationand the PD-L1–positive subgroup.