Abstract: ObjectiveTo explore the effect of ginsenoside Rg3 (Shenyi Capsule) combining with Capecitabine on antitumor efficacy, mechanism, toxicity and quality of life in patients with advanced breast cancer. MethodsThe prospective, randomized, controlled method was adopted. 56 patients with advanced breast cancer were randomly assigned to trial group (28 cases)and contral group(28 cases), the trial group was administered with ginsenoside Rg3 combining with Capecitabine and the contral group was administered with Capecitabine alone. ResultsThe response rate in trial group and control group was 35.7% and 25%, respectively. The 1-year survival rate was 68% and 50%, respectively. There was no significant difference between the 2 groups (P>0.05). Results: In trial group, the major hematologic toxicities was neutropenia 17.9%, with a 7.1% fatigue,while the rates of neutropenia and fatigue were 42.9% and 32.1% in control group，respectively. There was significant difference between the two groups in this case.Compared with the control group, the vascular endothelial growth factor (VEGF) value was significantly reduced and the quality of life was significantly improved in the trial group. ConclusionGinsenoside Rg3 combining with Capecitabine trended to prolong the survival time of patients with advanced breast cancer. Moreover, ginsenoside Rg3 could reduce the adverse effects of chemotherapy and improve the quality of life. The mechanism might be correlated with its antiangiogenic effect.