Objective To observe the effect of Chinese herbal medicine Guben Yiliu（Reinforce Physical Constitution to Resist Tumor） Ⅱ in the treatment of advanced breast cancer.Methods The 59 cases of recurrent or metastatic breast cancer were randomly divided into treatment and control groups.Both groups were treated with NP（Navelbine + cisplatin）.The treatment group took Guben Yiliu Ⅱ as well.The changes in the scores of size of tumor

TCM symptoms

tumor markers and quality of life before and after treatment were observed.Results In the treatment group

the remission rate was 50.0% and the clinical benefit rate 92.9%

while in the control group

it was 40.7% and 81.5% respectively.The total scores of TCM symptoms of two groups were not significantly different from each other

but the improvement and stabilization rate of hypodynamia

numbness of limbs and soreness in lumbus and knees in treatment group was better than that in the control group（P <0.05 or P<0.01）.After treatment

there was no significant change of quality of life in treatment group but a clear descendent in control group.The tumor markers of both groups were reduced to different degrees

of which

the CEA reduction of treatment group was more than that in control group

and the difference was significant（P <0.05）.Conclusion Guben Yiliu Ⅱ plays a role in synergy and toxin-removing in the treatment of advanced breast cancer.Chinese herbal medicines replenishing qi

activating blood and detoxication might be as the sensitizer of chemotherapy.