Objective To explore the clinical efficacy of modified Ruai Shuhou Formula（ 乳癌术后方） in triplenegative breast cancer patients. Methods This study was a single-group retrospective and prospective two-way observational study using a single-group clinical trial target value method with a target value of 86. 4%. A total of 70 patients with stage Ⅰ to Ⅲ triple-negative breast cancer were enrolled

and treated with modified Ruai Shuhou Formula

1 dose per day

400 m L decoction taken in the morning and evening

for at least 6 months. With 3 years of follow-up

the three-year disease-free survival rate was observed and compared with the target value. Results All70 patients with triple-negative breast cancer were female

aged 31 to 81 years

averaging（ 56. 73 ± 11. 68） years

including 63 cases of invasive ductal carcinoma

and 7 other types; 21 cases in stage Ⅰ

39 cases in stage Ⅱ

and10 cases in stage Ⅲ. The median follow-up time was 40 months and the mean follow-up time was 47. 13 months. The three-year disease-free survival rate was 94. 3%

which was statistically significant compared with the target group of86. 4%（ P = 0. 027）. Conclusion The modified Ruai Shuhou Formula can improve the three-year disease-free survival rate of triple-negative breast cancer.