Objective To evaluate the safety and efficacy of neoadjuvant chemotherapy combined with PA-MSHA injection for the treatment of locally advanced breast cancer. Methods An open, randomized, controlled clinical trial was conducted in this study. 42 locally advanced breast cancer patients were randomly assigned to two groups, namely the experimental group (20 cases) and control group (22 cases). All the patients received chemotherapy of TEC regimen, while, in addition, the patients in experiment group received PA-MSHA injection. After the treatment, the efficacy of treatment was evaluated. The safety and tolerance of patients were also measured during the treatment. Results The overall response rate (CR+PR) [75.0 %(15/20)]in the experiment group was significant higher than that [54.6 %(12/22)]in control group (P < 0.01). Adverse reactions were found for 9 cases in experiment group, four of whom received medical care while the others recovered automatically. Conclusion PA-MSHA injection can significantly enhance the efficaey of neoadjuvant chemotherapy on the patients with locally advanced breast cancer. The PA-MSHA injection which has been proved safety in treatment is an ideal supplementary therapy for breast cancer.