Multicenter phase 2 trial of pyrotinib plus capecitabine for HER2-positive breast cancer with brain metastases

Patients with HER2-positive metastatic breast cancer have a high risk of developing brain metastases. Efficacious treatment options are scarce. The multicenter phase 2 PERMEATE trial in China investigated the activity and safety of the combination of pyrotinib (HER2 TKI) with capecitabine in patients with HER2-positive metastatic breast cancer and brain metastases. The intracranial objective response rate was 74.6% in the radiotherapy-naïve cohort and 42.1% in the cohort of patients with progressive disease after radiotherapy. The median progression-free survival in the two cohorts was 11.3 months and 5.6 months. Toxicity was manageable. The authors conclude that this combination deserves further validation in a randomized trial.