Vinorelbine is a newanti-cancer drug that is available for advanced or metastatic breast cancer, approved by the Japanese Ministry of Health, Labour and Welfare in May 2005. At present, we evaluated the efficacy and safety of vinorelbine in our hospital. 51 patients were treated with vinorelbine since April 1, 2006 to August 20, 2007. Average age was 55.9 years old and period of treatment was 161.9 days. Average number of previous treatments was 2.2, and 37 patients(72.6%)were treated with anthracyclines and taxanes. The response rate was 19.6%, there was one complete responder, and nine partial responders. Especially, the response rate was 16.2% in patients pretreated with anthracyclines and taxanes. The major toxicity was grade 3 or 4 neutropenia(15.7%), and superficial phlebitis(7.8%). Vinorelbine will be a standard treatment agent for patients pretreated with anthracyclines and taxanes.