Objective To observe clinical efficacy and related factors of pathological complete response（ p CR）rates in tiple-negative breast cancer（ TNBC） patients using Sanyeqing Sanjie Kang’ ai Formula after neoadjuvant chemotherapy. Methods Totally 107 TNBC patients were randomly divided into treatment group of 55 cases and control group of 52 cases. Control group was treated with FEC regimen

i. e. 5-fluorouracil 500 mg / m2+ epirubicin90 mg / m2+ cyclophosphamide 600 mg / m2

or TEC regimen

i. e. docetaxel 75 mg /m2+ epirubicin 60 mg / m2+ cyclophosphamide 500 mg / m2

once every 21 days. Treatment group took Sanyeqing Sanjie Kang’ai Formula three days after every round of chemotherapy

1 dose per day

for 2 weeks. Patients underwent breasts ultrasound and magnetic resonance enhanced scan before treatment and after the 2nd and 4th cycle of chemo. Surgery was done after 2 weeks of the 4th cycle of chemotherapy. Then we make assessment of p CR rates and analyze the correlation of p CR rates with clinical

molecular pathological indicators. Results After 4 weeks of FEC regimen neoadjuvant chemotherapy

treatment group’s p CR rate was 30. 43%

superior to 4. 76% of the control group（ P < 0. 05）. After 4 weeks of TEC regimen neoadjuvant chemotherapy

treatment group’s p CR rate was 31. 25%

superior to 9. 68% of the control group（ P < 0. 05）. Single factor analysis showed that CK5 /6 positive and breast cancer 1 correlated positively with p CR in treatment group（ P < 0. 05）. Conclusion Sanyeqing Sanjie Kang’ai Formula can improve TNBC patients’ p CR after neoadjuvant chemotherapy effectively and performs better on patients with CK5 /6 positive and breast cancer 1 mutation.