There have been many recent advances in the treatment of advanced breast cancer including the introduction of novel drugs and the development of high-dose chemotherapy with peripheral blood stem cell transplantation (PBSCT). These innovations may offer significant hope for improvement in the treatment of breast cancer in the near future. Gemcitabine is a nucleoside analogue with significant antitumour activity in many human solid tumours. Conflicting results have been observed from studies evaluating gemcitabine in advanced breast cancer. Efficacy data for single-agent gemcitabine range from 25 to 46% depending on starting dose and whether patients have previously received chemotherapy for metastatic disease (as well as adjuvant use). Gemcitabine is extremely well tolerated, even in heavily pre-treated patients, and is easy to administer on an outpatient basis to both chemo-naive and previously treated patients. The most common toxicity is mild myelosuppression. Gemcitabine causes minimal nausea and vomiting, and significant hair loss is extremely uncommon. Combination chemotherapy studies with anthracyclines are underway and significant activity has been observed in combination with both doxorubicin and epirubicin. In view of its modest toxicity profile, and its novel mechanism of action, gemcitabine warrants further evaluation in breast cancer patients, both as a single agent and in combination chemotherapy schedules. (C) 1997 Elsevier Science Ltd.