Schmid P, Cortes J, Pusztai L, et al. - This study was attempted to evaluate the utility and safety of pembrolizumab for early triple-negative breast cancer. A total of 602 individuals were included in this study. Individuals were randomized in a 2:1 ratio with previously untreated stage II or stage III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin (784 individuals; the pembrolizumab–chemotherapy group) or placebo every 3 weeks plus paclitaxel and carboplatin (390 individuals; the placebo–chemotherapy group); the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin–cyclophosphamide or epirubicin–cyclophosphamide. The primary outcomes included a pathological complete response at the time of definitive surgery and event-free survival in the intention-to-treat population. 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 among individuals with early triple-negative breast cancer.