To observe the influence of Shuyu Pill on leukocyte and Ki-67 of 60 women breast cancer patients who received EC chemotherapy before operation. Methods: The 60 patients were randomly divided into two groups: TCM group (30 cases) and control group (30 cases) and both of the group received four periods of chemotherapy. The TCM group was given Shuyu Pill after the third period of chemotherapy till finishing the fourth period, 30 days in total. The control group received regular chemotherapy. We observed the clinical symptoms of TCM and change of leukocyte after treatment, and compared the difference of Ki-67 before and after operation. Results: 1）The score on TCM clinical symptoms of TCM group was significantly lower than control group (P<0.05). 2）The number of leukocyte of patients in TCM group improved a lot comparing to the control group (P<0.05). 3）After the treatment, the positive expression rate of Ki-67 in TCM group reduced comparing to the control group (P<0.05). Conclusion: 1）Shuyu Pill could obviously improve clinical symptoms of TCM of breast cancer patients during chemotherapy and enhanced the patients life qualities. 2）Shuyu Pill could prevent decrease of the number of leukocyte due to chemotherapy and improve patients immunity. 3）Shuyu Pill could assist chemotherapy reducing positive expression rate of Ki-67. It helps preventing recurrence and metastasis of cancer and improving survival rate.