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

Breast Cancer Clinical Trial

Official title:

A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05914753
• Other study ID #: XHWBC
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: Zhejiang Provincial People's Hospital
• Contact: Hongchao Tang
• Phone: +8613282037232
• Email: thc0571[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect

Intervention

Drug:
• Epirubicin, 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, Cyclophosphamide, Docetaxel
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W,4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W,4 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR)	Pathological complete response	six months