Abstract： Objective： To observe the clinical effect of Fangji Huangqi Decoction combined with epirubicin+cyclophosphamide (EC) regimen on breast cancer and its effect on serum lactate dehydrogenase (LDH) and ki-67 levels. Methods：A total of 100 cases of patients with breast cancer were divided into the chemotherapy group and the Chinese medicine group according to the random number table method，with 50 cases in each group. The chemotherapy group was treated with EC regimen，and the Chinese medicine group was additionally treated with Fangji Huangqi Decoction based on the treatment of the chemotherapy group. After four consecutive courses of treatment，the short-term efficacy，Quality of Life Scale scores， levels of LDH，ki-67，immune cells (CD4+，CD8+ and CD4+/CD8+) and the incidence of complications were compared between the two groups. Results：After treatment，the total effective rate was 60.00% in the Chinese medicine group and 40.00% in the chemotherapy group，the difference being significant (P＜0.05). Quality of Life Scale scores in the two groups were increased when compared with those before treatment (P＜0.05)， and Quality of Life Scale score in the Chinese medicine group was higher than that in the chemotherapy group (P＜0.05). After treatment， the levels of CD8+ ， LDH and ki-67 in the two groups were decreased when compared with those before treatment (P＜0.05)，and the levels of CD4+ and CD4+/ CD8+ were increased when compared with those before treatment (P＜0.05)；the levels of CD8+，LDH and ki-67 in the Chinese medicine group were lower than those in the chemotherapy group (P＜0.05)，and the levels of CD4+ and CD4+/CD8+ were higher than those in the chemotherapy group (P＜0.05). After treatment， the incidence of edema， alopecia， hand and foot syndrome， and nausea and vomiting were 26.00%， 22.00%， 14.00% and 10.00% respectively in the Chinese medicine group， and 46.00%， 44.00%， 36.00% and 32.00% respectively in the chemotherapy group， differences being significant (P＜0.05). Conclusion： Fangji Huangqi Decoction combined with EC regimen has a significant clinical effect in the treatment of breast cancer，which can effectively down-regulate the levels of serum ki-67 and LDH，and improve immune function and quality of life of patients，with relatively fewer adverse reactions.