Abstract: Objective To observe the efficacy of traditional Chinese medicine（TCM） syndrome differentiation treatment for breast cancer patients with high risks of recurrence and metastasis. To evaluate the TCM treatment's influences of survival and survival rates in these highrisk patients. Methods By using prospective cohort study， taking standardization of TCM syndrome differentiation treatment as exposed factors， patients with highrisks breast cancer staged ⅡA to ⅢC were selected. The subjects were divided into 4 queues： TCM combination with western medicine queue （accepted TCM syndrome differentiation treatment and endocrine therapy）， TCM queue （accepted TCM syndrome differentiation treatment only）， western medicine queue （accepted hormone therapy only） and observation queue （didn't accept therapy）. To compare the four queues' accumulative disease-free survival （DFS） rates， accumulative overall survival （OS） rates， median DFS and OS. Results The 1-， 2- and 3-year accumulative disease-free survival rates of TCM combination with western medicine queue， western medicine queue and TCM queue were higher than observation queue's， and the difference was statistically significant（P＜0.05）.The accumulative overall survival rates of four queues had no statistical differences（P＞0.05）.To the end of the followup， in 354 postoperative breast cancer patients with high recurrence metastasis risks， 65 patients were relapsed or with metastasis， 8 were dead. The median DFS of patients with recurrence and metastasis in TCM combination with western medicine queue， TCM queue， western medicine queue and observation queue was respectively 17.00 months（95％CI：13.97-25.41）， 16.87 months（95％CI：9.8-40.8）， 13.93 months（95％CI：10.9-25.61） and 12.61 months（95％CI：10.41-14.45）. There was no statistically significant difference of median DFS in four queues patients with recurrence or metastasis. The difference of the 1-， 2- and 3-year accumulative diseasefree survival rates in four queues patients staged ⅢB to ⅢC was statistical significance（P＜0.05）. Among them， the accumulative diseasefree survival rates of TCM combination with western medicine queue， western medicine queue and TCM queue were higher than observation queue's， and the difference was statistically significance（P＜0.05）. It was no statistically significance in four queues accumulative verall survival at each tumor stage（P＞0.05）. Conclusion TCM based on syndrome differentiation can improve the accumulative disease-free survival rates of hormone receptor negative and postoperative breast cancer patients at high risks of recurrence or metastasis， especially for patients with cancer stage ⅢB to stage ⅢC. No matter what kind of treatment， it is not obvious in the short term prolong diseasefree survival or overall survival in these patients.