OBJECTIVE: To probe into the clinical efficacy of Kang’ ai injection combined with paclitaxel and carboplatin in the treatment of triple-negative breast cancer and its effects on inflammatory factors. METHODS: Eightyfour triple-negative breast cancer patients admitted into the First Hospital of Qinhuangdao from May 2019 to May 2021 were extracted to be divided into the control group and the treatment group via the random number table, with 42 cases in each group. The control group was treated with paclitaxel and carboplatin regimen, while the treatment group received Kang’ai injection combined with paclitaxel and carboplatin. The levels of tumor markers [carcinoembryonic antigen ( CEA), carbohydrate antigen 153 ( CA153 ), carbohydrate antigen 125 ( CA125 )], immune function (CD3+, CD4+, CD8+, CD4+ / CD8+ ), QOL-BREF score, serum inflammatory factors [C-reactive protein ( CRP), tumor necrosis factor-α (TNF-α), interleukin-6(IL-6)] of two groups were compared, and the clinical efficacy and adverse drug reactions were recorded. RESULTS: The total effective rate of treatment group was higher than that of control group [92. 86% (39 / 42) vs. 73. 81% (31 / 42)], the difference was statistically significant (P = 0. 019). After treatment, the levels of tumor markers in two groups decreased significantly, and the levels of CEA, CA153 and CA125 in the treatment group were significantly lower than those in the control group, the differences were statistically significant (P<0. 05). Compared with before treatment, CD3+, CD4+ and CD4+ / CD8 + in two groups increased, and CD8+ decreased after treatment; compared with the control group, CD3+, CD4+ and CD4+ / CD8 + in the treatment group were higher, and CD8+ was lower after treatment, the differences were statistically significant (P<0. 05). Compared with before treatment, the QOL-BREF score of two groups increased after treatment, and the QOL-BREF score of the treatment group was higher than that of the control group after treatment, the differences were statistically significant (P<0. 05). After treatment, the levels of serum inflammatory factors in two groups decreased significantly; compared with the control group, the levels of CRP, TNF-α and IL-6 in the treatment group were lower after treatment, the differences were statistically significant (P<0. 05). The incidence of adverse drug reactions in the treatment group was 7. 14% (3 / 42), lower than 23. 81% (10 / 42) in the control group, the difference was statistically significant (P = 0. 035). CONCLUSIONS: The clinical efficacy of Kang’ ai injection combined with paclitaxel and carboplatin in the treatment of triple-negative breast cancer is significant, which can not only reduce the levels of tumor markers and inflammatory factors, but improve the immune function and patients’ quality of life with few adverse drug reactions. [ABSTRACT FROM AUTHOR]