We have evaluated the efficacy and safety of the combination of capecitabine and vinorelbine in metastatic breast cancer (MBC) patients previously treated with anthracycline- and taxane-containing regimens. Between April 2000 and September 2002, 44 female MBC patients received oral capecitabine (1,250 mg/m2 twice daily on days 114), and intravenous vinorelbine (25 mg/m2 on days 1 and 8) during each 3 week-chemotherapy cycle (median, 5 cycles/patient; total, 235 cycles). One patient achieved a complete response and 21 patients had partial responses, giving an overall response rate of 50% in the intention-to-treat analysis (95% CI, 35.0-65.0%). Median duration of response was 6.0 months (range 1.2-23.0 months). Patients were followed-up for a median of 16 months, with median progression-free survival being 5.3 months, and median overall survival being 17 months. Toxicities included grades III and IV neutropenia in 63 (26.8%) and 4 (1.7%) cycles, respectively, and grades II and III hand-foot syndrome in 12 (5.1%) and 4 (1.7%) cycles, respectively. Other nonhematologic toxicities were minimal and manageable. In conclusion, the combination of capecitabine and vinorelbine was effective and well tolerated in MBC patients even after treatment with anthracyclines and taxanes.