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

Sponsor

Zhejiang Provincial People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05914753

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Chemotherapy Effect	Drug: Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel Drug: Epirubicin, Cyclophosphamide, Docetaxel	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 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 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
Placebo Comparator: Control group 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 Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W，4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W，4 cycles

Arm

Intervention/Treatment

Experimental: Experimental group

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

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

Placebo Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

Pathological complete response (pCR) [six months]
Pathological complete response

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Zhejiang Provincial People's Hospital

Investigators

Study Chair: Xuli Meng, Zhejiang Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuli Meng, Chief physician, Zhejiang Provincial People's Hospital

ClinicalTrials.gov Identifier:

NCT05914753

Other Study ID Numbers:

XHWBC

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023