Clinical and pharmacokinetic study of sunitinib and docetaxel in women with advanced breast cancer.

Abstract Background This exploratory study examined the pharmacokinetics, safety, and antitumor activity of sunitinib plus docetaxel in patients with HER-2-negative advanced breast cancer. Patients and methods Patients with HER-2-negative disease who had received prior adjuvant anthracycline-based therapy received docetaxel (75 mg/m 2 ) on day 1 of each 3-week cycle followed by sunitinib (37.5 mg/day for 2 weeks on Schedule 2/1) starting on day 2 (day 3 on cycle 2). Results Twenty-two patients were enrolled. No clinically significant drug–drug interactions were observed. The most common non-hematologic AE (any grade) was fatigue/asthenia. Grade 4 neutropenia occurred in 20/22 patients (91%; n  = 7 had neutropenic fever). The safety profile was similar to each agent given individually. 14/19 (73.7%) evaluable patients had a PR and 5/19 (26.3%) had SD. Conclusions Sunitinib plus docetaxel on Schedule 2/1 did not result in any clinically significant drug–drug interactions. This combination was manageable and exhibited antitumor activity.