Docetaxel (Taxotere) and gemcitabine (Gemzar) are active agents against breast cancer. Several phase I studies evaluated different schedules of their combination and clearly demonstrated that docetaxel and gemcitabine can be safely combined in either an every 3-week schedule or in a weekly and biweekly schedule. The toxicity profiles of these combinations were mainly grade 3 and 4 neutropenia and asthenia. Phase I studies also suggested that the docetaxel/gemcitabine combinations are active regimens in pretreated patients with advanced breast cancer. Three phase II studies of patients previously treated with anthracycline-based chemotherapy reported a mean objective response rate of 46% and a mean overall survival of 13.5 months. Two of these trials enrolled patients with anthracycline-resistant or anthracycline-refractory disease; the objective responses using docetaxel/gemcitabine combination were 36% to 55% and 54%, respectively. It is noteworthy that objective responses were also achieved with this regimen in some patients who progressed while receiving taxane-based, front-line chemotherapy. These efficacy results were obtained with a mild toxicity profile. Adverse events were of short duration and easily manageable. Further studies are needed to evaluate this combination as front-line chemotherapy as well as second-line in well-defined subgroups of patients with advanced breast cancer. Furthermore, the combination should be compared with other more standard or investigational regimens.