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

Authors:	Giuseppe Curigliano Xavier Pivot Javer Cortés Anthony Elias Rossano Cesari Reza Khosravan Mary Collier Xin Huang Patricia E Cataruozolo Kenneth A Kern Aron Goldhirsch

Institution:	1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea;2. Department of Hemato-Oncology, Konkuk Medical Center, University of Konkuk College of Medicine, Gwangjin-gu, Seoul, Korea

Abstract:	PurposeThis 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).MethodsPatients with advanced TNBC, relapsed after anthracycline- and taxane-based chemotherapy, were randomized to receive either sunitinib (37.5 mg/day) or the investigator's choice of SOC therapy. Progression-free survival was the primary endpoint.ResultsMedian 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).ConclusionsSunitinib 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 registrationNCT00246571.

Keywords:	Sunitinib Triple-negative breast cancer Standard-of-care chemotherapy Phase II Receptor tyrosine kinases BC"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"Breast Cancer TNBC"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"Triple-negative breast cancer ER"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"the estrogen receptor HER2"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"human epidermal growth factor receptor 2 VEGFR"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"vascular endothelial growth factor receptor PDGFR"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"platelet-derived growth factor receptor KIT"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"stem-cell factor receptor CSF-1R"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"and colony-stimulating factor-1 receptor CDD"} {"#name":"keyword" "$":{"id":"kwrd0120"} "$$":[{"#name":"text" "_":"continuous daily dosing PFS"} {"#name":"keyword" "$":{"id":"kwrd0130"} "$$":[{"#name":"text" "_":"progression-free survival SOC"} {"#name":"keyword" "$":{"id":"kwrd0140"} "$$":[{"#name":"text" "_":"standard-of-care ORR"} {"#name":"keyword" "$":{"id":"kwrd0150"} "$$":[{"#name":"text" "_":"objective response rate OS"} {"#name":"keyword" "$":{"id":"kwrd0160"} "$$":[{"#name":"text" "_":"overall survival RECIST"} {"#name":"keyword" "$":{"id":"kwrd0170"} "$$":[{"#name":"text" "_":"Response Evaluation Criteria in Solid Tumors CT"} {"#name":"keyword" "$":{"id":"kwrd0180"} "$$":[{"#name":"text" "_":"computed tomography MRI"} {"#name":"keyword" "$":{"id":"kwrd0190"} "$$":[{"#name":"text" "_":"spiral CT or magnetic resonance imaging"} {"#name":"keyword" "$":{"id":"kwrd0200"} "$$":[{"#name":"text" "_":"AEs adverse events"} {"#name":"keyword" "$":{"id":"kwrd0210"} "$$":[{"#name":"text" "_":"NCI CTCAE v3 0 National Cancer Institute Common Terminology Criteria for Adverse Events"} {"#name":"keyword" "$":{"id":"kwrd0220"} "$$":[{"#name":"text" "_":"version 3 0 CI"} {"#name":"keyword" "$":{"id":"kwrd0230"} "$$":[{"#name":"text" "_":"confidence interval RDI"} {"#name":"keyword" "$":{"id":"kwrd0240"} "$$":[{"#name":"text" "_":"relative dose intensity
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