Abstract： Objective： To observe the clinical effect of Fuzheng Yiqi Formula Prescription with Trastuzumab for human epidermal growth factor receptor 2 (HER- 2) positive breast cancer. Methods： A total of 75 cases of patients with HER-2 positive breast cancer were retrospectively studied and divided into the Chinese medicine combination group and the control group according to the treatment plan ， with 39 and 36 cases in each group respectively. The control group was treated with intravenous injection with Doxorubicin Liposome，Docetaxe，Paclitaxel，and Trastuzumab，and the Chinese medicine combination group was additionally treated with Fuzheng Yiqi Prescription based on the treatment of the control group. Both groups were treated for 18 weeks. The recurrence and metastasis of tumor， and the disease- free survival after treatment were compared between the two groups. Traditional Chinese medicine syndrome (TCM) scores， Functional Assessment of Cancer Therapy (FACT- G) ， and the contents of carcinoembryonic antigen (CEA) and carbohydrate antigen 153 (CA153) in serum in the two groups were compared before and after treatment. Results： The rate of complete remission (CR) and partial remission (PR) was 58.97% in the Chinese medicine combination group，higher than that of 44.44% in the control group (P＜0.05). Before treatment， there was no significant difference being found in the comparison of TCM syndrome scores between the two groups (P＞0.05). After treatment，TCM syndrome scores in the two groups were decreased (P＜0.05)，and the score in the Chinese medicine combination group was lower than that in the control group (P＜0.05). After treatment，the disease-free survival time in the Chinese medicine combination group was longer than that in the control group (P＜0.05). Before treatment，there was no significant difference being found in the comparison of FACT-G scores between the two groups (P＞0.05). After treatment，FACT-G scores in the two groups were decreased (P＜0.05)， and the score in the Chinese medicine combination group was lower than that in the control group (P＜0.05). Before treatment，there was no significant difference being found in the comparison of the levels of CEA and CA153 in serum between the two groups (P＞0.05). After treatment，the levels of CEA and CA153 in serum in the two groups were decreased (P＜0.05)，and the levels in the Chinese medicine combination group were lower than those in the control group (P＜0.05). Conclusion： Fuzheng Yiqi Prescription combined with Trastuzumab for HER- 2 positive breast cancer can prolong the postoperative disease-free survival，postpone the disease，and improve the quality of life of patients.