Abstract: Objective : To evaluate the efficacy and toxicity of paclitaxel and epirubicin (TE regimen) versus navelbine and epirubicin (NE regimen) in the treatment of advanced breast cancer. Methods : A total of 70 patients with advanced breast cancer proved pathologically were randomly divided into TE group (n=34) and NE group (n=36). Results : TE regimen produced a higher response rate (RR)than NE regimen in the whole cases (64.7% and 38.9%, respectively) and the retreatment cases (60.0%and 28.6%, respectively) (P<0.05). The median time to progress (TTP) in TE group was longer than that in NE group(9.6 months and 7.2 months, respectively) (P<0.05). However, there was no significant difference between two groups in the RR of the initial treatment and the median survival (P>0.05). The main toxicities were bone marrow depression#digestive reaction and alopecia (mainly grade Ⅰ～Ⅱ),which were similar in two groups. Phlebitis was more common in NE group than in TE group, but articular and muscular soreness was more serious in TE group. All side effects were toleable. Conclusions : Both of the two regimens are effective and well-tolerated in the treatment of advanced breast cancer. However, TE regimen is more effective in retreatment cases, and could be considered as a relevant regimen for retreated patients.