We evaluated the efficacy and safety of the combination of docetaxel and cisplatin in metastatic breast cancer (MBC) patients previously treated with anthracycline-containing regimens. Between June 1999 and December 2002, 50 female MBC patients (median age 43 years; range 29-64) received docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) on day 1 of each 4-week cycle. A total of 226 cycles (median four cycles per patient) were administered as first-line (23 patients) or second-line (27 patients) treatment. Five patients (10%) achieved a complete response (CR) and 15 (30%) had partial responses (PR), giving an overall response rate of 40% (95% CI, 26.4 approximately 53.6%). The median duration of response was 6.1 months (range, 2.3 approximately 29.2(+) months). With a median follow-up of 15.9 months, median time to progression was 6.2 months (range 1 approximately 22.5(+) months). Toxicities included grades III and IV neutropenia in nine (18%) and ten (20%) patients, respectively, and febrile neutropenia in seven patients (14%). In conclusion, our data show that docetaxel plus cisplatin is effective with the manageable toxicity profile in MBC patients previously treated with anthracyclines.