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Objective. The traditional Chinese medicine Kangai injection as an adjuvant method in combination with chemotherapy has been widely used for treating breast cancer in clinical practice in China. This study systematically reviewed the clinical effect and safety of traditional Chinese medicine Kangai injection as an adjuvant method in combination with chemotherapy for treating Chinese patients with breast cancer. Methods. Seven databases were searched in this study, namely, PubMed, the Cochrane Library, Embase, CNKI, Sino Med, VIP, and Wanfang Data. The timeframe of retrieval was set from the founding date of each database to November 1, 2017. Results. Fifteen papers were included in this study. The quality of all the studies included was low. All the studies were carried out among the Chinese population. Meta-analyses showed that, compared with single-use chemotherapy, using a Kangai injection combined with chemotherapy to treat Chinese breast cancer patient can increase the total effective rate [RR = 1.15, 95% CI (1.01, 1.32), and P=0.033], improve the quality of life [RR = 1.30, 95% CI (1.14, 1.48), and P≤0.001], decrease the incidence of weight loss [RR = 0.49, 95% CI (0.32, 0.77), and P=0.002], decrease WBC count [RR = 0.78, 95% CI (0.68, 0.89), and P≤0.001], decrease incidence of renal and liver dysfunction [RR = 0.58, 95% CI (0.46, 0.73), and P≤0.001], and decrease cardiac dysfunction [RR = 0.41, 95% CI (0.18, 0.94), and P=0.035]. For the incidence of gastrointestinal adverse reactions [RR = 0.89, 95% CI (0.65, 1.21), and P=0.452], decreased platelet count [RR=0.49, 95% CI (0.18, 1.30), and P=0.150], and alopecia [RR = 1.01, 95% CI (0.89, 1.14), and P=0.879], these two groups showed no statistically significant differences. Conclusion. Kangai injection as an adjuvant method in combination with chemotherapy for treating Chinese breast cancer patients can improve their life quality and physical conditions and reduce the adverse reactions that result from chemotherapy. However, the present conclusion is only suitable for the Chinese population. The long-term, high-quality researches are required to further verify the above conclusions. [ABSTRACT FROM AUTHOR]