Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer

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

Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.
  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 surgicaltreatment;
  6. At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy ofchemotherapy was evaluated at the end of chemotherapy and after surgery;
  7. Under the guidance of doctors, take Xihuang pills in a standardized way throughout thewhole process and review regularly;
  8. The patient did not receive any antitumor therapy drugs associated with the tumorprior to neoadjuvant chemotherapy;
  9. All patients were newly diagnosed

Exclusion

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 chemotherapydrugs;
  9. Inflammatory breast cancer, bilateral breast cancer, paget's disease and other specialtypes of breast cancer;
  10. 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

Study 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.