pembrolizumab
infusion of pembrolizumab (200 mg) every 3 weeks
placebo
infusion of placebo every 3 weeks
the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide, after definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. No crossover was permitted between the phases.
es-BC - TNBC - NA - all population
double blind
from 181 sites (plus 2 satellite sites) in 21 countries
P3/ one sided (0,025) two interim analysis. Repartition 0,005 pCR 0,02 EFS
Among patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy. results for final EFS are not yet published