Sutent is an investigational agent for breast cancer. Thus far, a Phase II study(Burstein et al) in previously-treated patients with metastatic breast cancer found that sunitinib “has significant single agent activitt; an objective response rate (ORR) of 11% was achieved and 5% of patients had stable disease (SD) for ≥ 6 months. Additionally, the ORR in patients with triple-negative tumors was 15%.
Burstein et al found that single-agent sunitinib had antitumor activity in patients with heavily pretreated MBC (N= 64): an objective response rate (ORR) of 11% was achieved and 5% of patients had stable disease (SD) for 6 months. The the ORR in patients with triple-negative tumors was 15%.
A phase III study against capecitabine(Xeloda) (was not encouraging. It concluded that based on efficacy and safety results, sunitinib should not be used as monotherapy for patients with ABC.
A phase III randomized open-label study of sunitinib malate in combination with paclitaxel versus bevacizumab with paclitaxel as a first-line treatment for patients with advanced breast cancer is now open and enrolling patients. There is also a phase II randomized, open-label study of sunitinib malate versus standard-of- care for patients with previously treated advanced triple receptor negative (ER-, PR- and HER2-) breast cancer at 44 international sites, including more than 25 in the US.
Miller KD et al.. “Phase II study of SU11248, a multi-targeted tyrosine kinase inhibitor in patients with previously treated metastatic breast cancer”. ASCO 2005
Burstein HJ, Elias AD, Rugo HS, Cobleigh MA, Wolff AC, Eisenberg PD, Lehman M, Adams BJ, Bello CL, DePrimo SE, Baum CM, Miller KD: Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2008, 26:1810– 1816.
Kiana Keyvanjah et al, Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib Journal of Translational Medicine 2012, 10:165
Carlos H. Barrios et al, Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Res Treat. 2010 May; 121(1): 121–131.