Single-center phase 2 trial of anlotinib plus chemotherapy for pretreated HER2-negative metastatic breast cancer

The management of HER2-negative metastatic breast cancer (mBC) in the second- or later-line setting is challenging, due to the lack of standardized regimens and the limited efficacy of chemotherapy. A phase 2 trial at Nanjing Medical University (China) evaluated the combination of anlotinib and chemotherapy in patients with HER2-negative mBC who had progressed after at least one previous line of systemic therapy for metastatic disease. The median number of previous systemic therapy lines among the 33 enrolled patients was 2 (range 1-4). The median follow-up was 25.9 months. With anlotinib plus chemotherapy, the median progression-free survival was 8.3 months (95% CI 6.3-10.2) whereas the median overall survival was 22.2 months (13.1-31.3). The objective response rate was 33.3% and the clinical benefit rate was 60.6%. The authors conclude that anlotinib plus chemotherapy demonstrated promising activity in patients with previously treated HER2-negative mBC.