Multicenter phase 2 trial of pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer

Patients with HER2-positive advanced breast cancer (ABC) and primary resistance to trastuzumab have a poor prognosis. The phase 2 PICTURE trial, at 16 centers in China, evaluated the combination of pyrotinib and capecitabine in this patient population. The median progression-free survival was 11.8 months (95% CI 8.4-15.1), which crossed the pre-specified efficacy boundary or 8.0 months. The objective response rate was 70%, with a median duration of response of 13.8 months (95%-bti 10.2-19.3), and the disease control rate was 87%. The median overall survival was not reached. Grade ≥ 3 TEAEs were reported by 56%. The authors conclude that pyrotinib plus capecitabine can be considered a treatment option for HER2-positive ABC with primary resistance to trastuzumab.