OBJECTIVE： To investigate the efficacy and safety of Xiaojin pill combined with docetaxel， epirubicin and cyclophosphamide in the treatment of breast cancer in stage Ⅲ and its effect on immune functions. METHODS： 102 patients with breast cancer in stage Ⅲ were randomly divided into control group （51 cases） and observation group（51 cases）. All patients were given symptomatic treatments as hydration，alkalization and antiemetic treatments in the duration of chemotherapy，and were given conventional treatments as 0.75 mg Dexamethasome oral tablets in 12 and 6 hours before the chemotherapy lespectively. Control group was given 75 mg/m2 Docetaxel injection， d1， intravenous infusion+60 mg/m2 Epirubicin hyclrochloride for injection， d1， intravenous infusion+600 mg/m2 Cyclophosphamide for injection， d1， intravenous infusion； observation group was additionally given 6 g Xiaojin pill， orally， twice a day. 21 d was regarded as a treatment course. Short-term clinical efficacy， immunoglobulin， T lymphocyte subsets （CD4+/CD3+， CD8+/CD3+， CD4+/CD8+） and the incidence of adverse reactions before and after chemotherapy in 2 groups after 2 courses were observed. RESULTS： There were no significant differences in the short-term effective rate and incidence of adverse reactions between 2 groups （P＞0.05）. Before chemotherapy， there were no significant differences in the immunoglobulin and T lymphocyte subsets between 2 groups （P＞0.05）. After chemotherapy， immunoglobulin levels in 2 groups were significantly lower than before， the differences were statistically significant （P＜0.05）； but there were no significant differences between 2 groups （P＞0.05）； CD4+/CD3+， CD8+/CD3+， CD4+/CD8+ in control group and CD8+/CD3+ in observation group were significantly lower than before， and CD4+/CD3+ and CD4+/CD8+ in observation group were higher than control group， the differences were statistically significant （P＜0.05）， but there was no significant difference in the CD8+/CD3+ between 2 groups （P＞0.05）. CONCLUSIONS： Based on the conventional treatment， Xiaojin pill combined with docetaxel， epirubicin and cyclophosphamide shows significant efficacy in the treatment of breast cancer in stage Ⅲ， and can improve immune functions， with good safety.