This Phase III randomized controlled trial investigated pembrolizumab combined with standard chemotherapy in 634 patients with early triple-negative breast cancer. The combination therapy demonstrated a pathological complete response rate of 64.8% compared to 51.2% in the chemotherapy-only arm (p<0.001). Event-free survival at 3 years was 84.5% vs 76.8%. The study supports pembrolizumab plus chemotherapy as a new standard of care for high-risk early TNBC.