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

Jonas Bergh, Gabriella Mariani, Fatima Cardoso, Annelie Liljegren, Ahmad Awada, Lucia Viganò, Xin Huang, Lev Verkh, Kenneth A. Kern, Carla Giorgetti, Luca Gianni

Research output: Contribution to journalArticlepeer-review


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/m2) 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.

Original languageEnglish
Pages (from-to)507-513
Number of pages7
Issue number4
Publication statusPublished - Aug 2012


  • Advanced breast cancer
  • Docetaxel
  • Sunitinib
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Surgery


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