Last updated: June 21, 2023
Sponsor: Zhejiang Provincial People's Hospital
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Breast Cancer
Cancer
Treatment
Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
Epirubicin, Cyclophosphamide, Docetaxel
Clinical Study ID
NCT05914753
XHWBC
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Biopsy of breast mass was performed under ultrasound-guided treatment beforeneoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmedpathologically, followed by immunohistochemical examination. Pathological sectionsbefore and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more seniorpathologists, and there were consistent definite conclusions.
- Have detailed and complete clinicopathological data;
- Diagnosis data of TCM syndrome type;
- No biopsy-confirmed lymph node metastasis;
- No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgicaltreatment;
- At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy ofchemotherapy was evaluated at the end of chemotherapy and after surgery;
- Under the guidance of doctors, take Xihuang pills in a standardized way throughout thewhole process and review regularly;
- The patient did not receive any antitumor therapy drugs associated with the tumorprior to neoadjuvant chemotherapy;
- All patients were newly diagnosed
Exclusion
Exclusion Criteria:
- Concurrent malignant tumors of other sites;
- Patients with distant metastasis
- Male breast cancer
- Patients who did not receive full-course standardized neoadjuvant chemotherapy;
- Lost contact or dropped out of the study, unable to follow up;
- Inability to tolerate chemotherapy responses;
- Intolerant to Xihuang Wan and unable to take it;
- The patient has strong side effects of chemotherapy and cannot tolerate chemotherapydrugs;
- Inflammatory breast cancer, bilateral breast cancer, paget's disease and other specialtypes of breast cancer;
- Various other possible influences.
Study Design
Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
Phase:
Study Start date:
July 01, 2023
Estimated Completion Date:
June 01, 2025