Aim of the study: The study examined

the response rate, response duration and toxicity of vinorelbine and fluorouracil or vinorelbine alone in pretreated metasta-tic breast cancer. Material and methods: Between June 2001 and September 2009, a group of 103 pa-tients with locally advanced or metasta-tic breast cancer, who had progressed after anthracycline/taxane chemothera-py, was treated with a vinorelbine-based regimen. The treatment consisted of vinorelbine 25 mg/m2 and 5-fluorouracil (5-FU) 500 mg/m2 administered intra-venously on days 1 and 8 of each cycle (53 patients) or vinorelbine alone at a dose of 30 mg/m2 on day 1 and 8 of the cycle, every 3 weeks (50 patients). Patients received chemotherapy as a second or fur-ther line of therapy. Treatment was con-tinued until disease progression or unac-ceptable toxicity. The median age of patients treated with vinorelbine with 5FU was 54 years (range 38–76), and 55.5 years (range 38–73) in the group receiv-ing vinorelbine monotherapy. A total of 417 cycles of chemotherapy were admin-istered – 177 cycles of vinorelbine with 5-FU and 137 cycles of vinorelbine monotherapy. Patients were treated for a median of 4 cycles (range: 1 to 11 cycles). The evaluation of treatment effect was possible in 93 patients (10 patients received only one treatment cycle). Results: The overall response rate (ORR) was 17 % (7), including 2 (4%) complet