Abstract
Background: We conducted a multiinstitutional phase II study of capecitabine in combination with vinorelbine and trastuzumab in patients eligible to receive first- or second-line treatment for human epidermal growth factor receptor type 2 (HER2)-positive (HER2+) metastatic breast cancer (MBC). Patients and Methods: The study was designed to test that the true confirmed response rate (CRR) was at most 45% vs. a true CRR of at least 65%. Between March 2005 and June 2008, eligible patients received capecitabine 825 mg/m2 orally on days 1 to 14, vinorelbine 25 mg/m2 intravenously on days 1 and 8 every 3 weeks, and trastuzumab 8 mg/kg intravenously on day 1 week 1 and 6 mg/kg every 3 weeks. The main outcome measure was CRR. Results: Of 47 women accrued, 45 were evaluable. This design required at least 25 confirmed responses in the 45 evaluable patients for the treatment to be considered promising. Thirty women (67%) achieved a confirmed response; 25 women (56%) had a confirmed partial response (PR); 5 women (11%) had confirmed complete responses (CRs). Median progression-free survival (PFS) was 11.3 months (95% confidence interval [CI], 8.4-16.7 months). Median overall survival was 28.5 months (95% CI, 24.8-36.4 months). Conclusions: This triplet combination demonstrated promising activity in patients with HER2+ MBC.
Original language | English (US) |
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Pages (from-to) | 81-86 |
Number of pages | 6 |
Journal | Clinical breast cancer |
Volume | 12 |
Issue number | 2 |
DOIs | |
State | Published - Apr 2012 |
Keywords
- Capecitabine
- Combination chemotherapy
- Metastatic breast cancer
- Trastuzumab
- Vinorelbine
ASJC Scopus subject areas
- Oncology
- Cancer Research