A pilot study conducted at the National Cancer Institute in Milan, Italy assessed the efficacy of six or eight cycles of paclitaxel (Taxol) 200 mg/m2 q3wks plus doxorubicin (Adriamycin) (60 mg/m2q3wks) in 49 women with metastatic breast cancer who had received no prior chemotherapy. This study suggested that paclitaxel and doxorubicin should be considered for previously untreated patients who have been initially diagnosed with metastatic breast cancer and have a good performance status. The probability of complete response in these patients can be enhanced by continuing treatment with single-agent paclitaxel, and the risk of cardiotoxicity can be minimized by keeping the cumulative dose of doxorubicin below 360 mg/m2. Based on the experience in Milan, this combination is one of the most effective regimens for the treatment of women with breast cancer. Indeed, the convenience, efficacy, and tolerability of the combination justify the large trials that are currently evaluating its effects in women with operable breast cancer.