Clinical trial · Interventional
Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
NCT05914753CI-TRIAL-00067413unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin, Cyclophosphamide, Docetaxel | Drug | — | UNRESOLVED |
| Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 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
- interventionNames
- Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- 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
- interventionNames
- Drug: Epirubicin, Cyclophosphamide, Docetaxel
Primary outcomes (1)
- measure
- Pathological complete response (pCR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.