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

Primary Purpose

Breast Cancer, Chemotherapy Effect

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
Epirubicin, Cyclophosphamide, Docetaxel
Sponsored by
Zhejiang Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental group

    Control group

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Pathological complete response (pCR)
    Pathological complete response

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2023
    Last Updated
    June 21, 2023
    Sponsor
    Zhejiang Provincial People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05914753
    Brief Title
    Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
    Official Title
    A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhejiang Provincial People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Chemotherapy Effect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Epirubicin, Cyclophosphamide, Xihuang Pill, Docetaxel
    Intervention 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
    Intervention Type
    Drug
    Intervention Name(s)
    Epirubicin, Cyclophosphamide, Docetaxel
    Intervention Description
    Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W,4 cycles, Follow Docetaxel :100 mg/m2, D1, q3W,4 cycles
    Primary Outcome Measure Information:
    Title
    Pathological complete response (pCR)
    Description
    Pathological complete response
    Time Frame
    six months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hongchao Tang
    Phone
    +8613282037232
    Email
    thc0571@live.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xuli Meng
    Organizational Affiliation
    Zhejiang Provincial People's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    After preliminary results are available, it is advisable to decide whether to share them with other researchers.

    Learn more about this trial

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

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