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

NCT ID: NCT05914753

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-06-01

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.

Conditions

Breast Cancer; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Experimental group: 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

Group Type: EXPERIMENTAL

Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel

Intervention Type: DRUG

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

Control group

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

Group Type: PLACEBO_COMPARATOR

Epirubicin, Cyclophosphamide, Docetaxel

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xuli Meng

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xuli Meng

Role: STUDY_CHAIR

Zhejiang Provincial People's Hospital

Central Contacts

Hongchao Tang

Role: CONTACT

thc0571@live.com

+8613282037232

Other Identifiers

XHWBC

Identifier Type: -

Identifier Source: org_study_id