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Trial Title:
Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
NCT ID:
NCT05914753
Condition:
Breast Cancer
Chemotherapy Effect
Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Docetaxel
Epirubicin
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
Description:
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
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Epirubicin, Cyclophosphamide, Docetaxel
Description:
Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow
Docetaxel :100 mg/m2, D1, q3W，4 cycles
Arm group label:
Control group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Source:
Zhejiang Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05914753
