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

NCT05914753 | Unknown

• 1 other identifier: XHWBC
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

Conditions

Breast Cancer; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR)

  Pathological complete response

  six months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel 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

Experimental group

Epirubicin, Cyclophosphamide, Docetaxel DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Xuli Meng

  Zhejiang Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Hongchao Tang

CONTACT

+8613282037232; thc0571@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share