Randomized phase II study of sunitinib versus standard of care forpatients with previously treated advanced triple-negative breast cancer

Purpose: This randomized, open-label phase II study compared the efficacy of sunitinib monotherapy with that of single-agent standard-of-care (SOC) chemotherapy in patients with previously treated advanced triple-negative breast cancer (TNBC). Methods: Patients with advanced TNBC, relapsed after anthracycline- and taxane-based chemotherapy, were randomized to receive either sunitinib (37.5mg/day) or the investigator's choice of SOC therapy. Progression-free survival was the primary endpoint. Results: Median progression-free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy (one-sided P=0.888). Median overall survival was not prolonged with sunitinib (9.4 months) compared with SOC chemotherapy (10.5 months; one-sided P=0.839). The objective response rate was 3% with sunitinib and 7% with SOC chemotherapy (one-sided P=0.962). Conclusions: Sunitinib monotherapy did not improve efficacy compared with SOC chemotherapy in patients with previously treated advanced TNBC, for which identification of effective treatments and therapeutic targets remains an urgent need. Trial registration: NCT00246571.