Breast Cancer, Chemotherapy Effect
Conditions
Brief summary
Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer
Detailed description
1. To evaluate the safety and effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use. 2. To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.
Interventions
DRUGEpirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; Xihuang Pill：3g po bid，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W；Xihuang Pill：3g po bid，4 cycles
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles
Sponsors
Zhejiang Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. Pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions. 2. Have detailed and complete clinicopathological data; 3. Diagnosis data of TCM syndrome type; 4. No biopsy-confirmed lymph node metastasis; 5. No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment; 6. At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery; 7. Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly; 8. The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy; 9. All patients were newly diagnosed
Exclusion criteria
1. Concurrent malignant tumors of other sites; 2. Patients with distant metastasis 3. Male breast cancer 4. Patients who did not receive full-course standardized neoadjuvant chemotherapy; 5. Lost contact or dropped out of the study, unable to follow up; 6. Inability to tolerate chemotherapy responses; 7. Intolerant to Xihuang Wan and unable to take it; 8. The patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs; 9. Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer; 10. Various other possible influences.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | six months | Pathological complete response |
Contacts
Primary ContactHongchao Tang
Outcome results
None listed