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

Study Overview
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Brief Summary
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Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

Detailed Description
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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. To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.

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

Conditions
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Breast Cancer, Chemotherapy Effect

Intervention / Treatment
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* Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
* Drug: Epirubicin, Cyclophosphamide, Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 surgical treatment; At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery; Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly; The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy; All patients were newly diagnosed 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 chemotherapy drugs; Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer; Various other possible influences.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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 | Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel<br>* 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<br>|
| Placebo Comparator: Control group<br>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 | Drug: Epirubicin, Cyclophosphamide, Docetaxel<br>* Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response (pCR) | Pathological complete response | six months |