title: Randomized phase II study of sunitinib versus standard of care for patients with previously treated advanced triple-negative breast cancer.
abstract: OBJECTIVE
  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 (37.5 mg/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.
  
  
  BACKGROUND
  NCT00246571.
authors: Early Drug Development for Innovative Therapies Division, Istituto Europeo di Oncologia, Via Ripamonti 435, 20141, Milano, Italy. Electronic address: giuseppe.curigliano@ieo.it.
authors: Giuseppe
authors: G
authors: Curigliano
authors: Xavier
authors: X
authors: Pivot
authors: Javer
authors: J
authors: Cortés
authors: Anthony
authors: A
authors: Elias
authors: Rossano
authors: R
authors: Cesari
authors: Reza
authors: R
authors: Khosravan
authors: Mary
authors: M
authors: Collier
authors: Xin
authors: X
authors: Huang
authors: Patricia E
authors: PE
authors: Cataruozolo
authors: Kenneth A
authors: KA
authors: Kern
authors: Aron
authors: A
authors: Goldhirsch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives / Q000627:therapeutic use; D060831:Hand-Foot Syndrome / Q000209:etiology; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000627:therapeutic use; D011758:Pyrroles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000077210:Sunitinib; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use; D013921:Thrombocytopenia / Q000139:chemically induced; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil; D000077210:Sunitinib; D000093542:Gemcitabine
keywords: AEs; BC; Breast Cancer; CDD; CI; CSF-1R; CT; ER; HER2; KIT; MRI; NCI CTCAE v3.0; National Cancer Institute Common Terminology Criteria for Adverse Events; ORR; OS; PDGFR; PFS; Phase II; RDI; RECIST; Receptor tyrosine kinases; Response Evaluation Criteria in Solid Tumors; SOC; Standard-of-care chemotherapy; Sunitinib; TNBC; Triple-negative breast cancer; VEGFR; adverse events; and colony-stimulating factor-1 receptor; computed tomography; confidence interval; continuous daily dosing; human epidermal growth factor receptor 2; objective response rate; or magnetic resonance imaging; overall survival; platelet-derived growth factor receptor; progression-free survival; relative dose intensity; spiral CT; standard-of-care; stem-cell factor receptor; the estrogen receptor; vascular endothelial growth factor receptor; version 3.0