Pembrolizumab and chemotherapy in high-risk, early-stage, ER⁺/HER2^- breast cancer: a randomized phase 3 trial.

ABSTRACT: Addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab improved outcomes in patients with high-risk, early-stage, triple-negative breast cancer. However, whether the addition of neoadjuvant pembrolizumab to chemotherapy would improve outcomes in high-risk, early-stage, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER⁺/HER2^-) breast cancer remains unclear. We conducted a double-blind, placebo-controlled phase 3 study (KEYNOTE-756) in which patients with previously untreated ER⁺/HER2^- grade 3 high-risk invasive breast cancer (T1c-2 (≥2 cm), cN1-2 or T3-4, cN0-2) were randomly assigned (1:1) to neoadjuvant pembrolizumab 200 mg or placebo Q3W given with paclitaxel QW for 12 weeks, foll

SUBMITTER: Cardoso F 

PROVIDER: S-EPMC11835712 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature