Abstract: Objective: To evaluate the efficacy and safety of Paclitaxel-Cisplatin regimen in treating advanced breast cancer. Methods: A total of 31 patients with advanced breast cancer were treated with combination of Paclitaxel and Cisplatin. Paclitaxel was administered at 135-175mg/m²iv d1, and Cisplatin was administered at 70mg/m²iv d2. Theabove regimen was repeated every 21~ 28 days. Results: The overall response rate was 58.1%, with a median time to pro-gression of 7 months. The median overall survival was 20 months. The 1-year, 3-year and 5-year overall survival rates were 61.5%, 22.3%, and 5.3%, respectively. The response rate was higher in patients with the initial treatment than in those with retreat ment (77.8% vs. 30.8%, P<0.05). The response rate was 50% in patients previously exposed to anthracy-clines and 66.7% in patients without previous exposure to anthracyclines. The response rate of patients with one or two metastatic leisions and those with more leisions was 65% and 45.5%, respectively (P>0.05). Compared with metastases of viscera, lymph nodes and soft tissues, the response rate of bone metastasis was relatively low (28.6%), but with no statisti-cal significance. The main side effects were myelosuppression, arthralgia, muscle pain, peripheral neuropathy, gastrointesti-nal toxicity, and abnormal hepatic function. Most of the above side effects were grade Ⅰ-Ⅱ. The main grade Ⅲ-Ⅳ sideeffects were leukopenia and gastrointestinal toxicity with an incidence of 16.1% and 12.9%, respectively. Conclusion: Thecombination of Paclitaxel and Cisplatin has high efficacy in patients with advanced breast cancer. The side effects are tol-erable.