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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Chemotherapy Effect
• Interventions: Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel; Drug: Epirubicin, Cyclophosphamide, Docetaxel

• Registration Number: NCT05914753
• Lead Sponsor: Zhejiang Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-21
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Study Start: 2023-07-01
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel	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
Control group	Epirubicin, Cyclophosphamide, Docetaxel	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

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR)	six months	Pathological complete response