ERBB2 and breast cancer: The safety and antitumor activity of pembrolizumab monotherapy have been assessed in the phase Ib KEYNOTE-028 trial enrolling heavily pre-treated ER+ HER2-advanced breast cancer patients with PD-L1-positive tumors (combined positive score ≥ 1) who received pembrolizumab monotherapy for up to 2 years or until confirmed progression/intolerable toxicity; the overall response rate (ORR) was 12%, 16% of patients had stable disease (SD), the clinical benefit rate was 20%, and the median duration of response was 12 months.