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Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Previous CDK4/6 i Adjuvant Therapy

Primary Purpose

Hormone Receptor-positive Advanced Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
chidamide combined with fulvestrant
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Receptor-positive Advanced Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female, ≥18 years old; ECOG score 0-1; Predicted survival ≥3 months; Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative ER2 expression; Patients who have relapsed or metastasized during or after CDK4/6 inhibitors combined with endocrine adjuvant therapy and have not received systemic antitumor therapy for the current stage of disease; No previous treatment with fluvestran or use of fluvestran without proven treatment failure; The time interval between non-endocrine therapy should be ≥2 weeks; At least one extracranial measurable lesion as defined by RECIST V1.1 criteria; The functions of vital organs meet the requirements; Fertile subjects must have a negative pregnancy test 7 days before starting treatment and must use an appropriate contraceptive method during treatment and for three months after completion of treatment; The patient is fully informed and voluntarily signs the informed consent. Exclusion Criteria: Prior treatment with any HDAC inhibitors; Known allergy to the tested drug component; inflammatory breast cancer at the time of screening; pia meningeal metastasis confirmed by MRI or lumbar puncture; Central nervous system metastasis confirmed by imaging; To the best of the investigator's judgment, symptomatic visceral disease or any disease load or none is considered optimal Endocrine therapy options are not suitable for endocrine therapy; Inability or unwillingness to swallow medication or receive intramuscular injections; Gastrointestinal insufficiency or gastrointestinal disease (if not controlled) that may significantly affect study drug absorption Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small intestine resection, etc.; Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms in the baseline period need drainage, or use it for the first time Patients with serous cavity drainage within 4 weeks before medication; A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, Or have a history of organ transplantation; Other malignancies (cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and Thyroid cancer is excluded); had undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or was expected to undergo major surgery Surgical treatment; Concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with patient completion of the study (e.g. Severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other activities Sexual infection); Inability to understand or follow research instructions and requirements; The researcher decides that it is not suitable to participate in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    chidamide combined with fulvestrant

    Arm Description

    chidamide combined with fulvestrant

    Outcomes

    Primary Outcome Measures

    ORR
    The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

    Secondary Outcome Measures

    PFS
    time to progressive disease (according to RECIST1.1)
    CBR
    The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
    DOR
    Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05806047
    Brief Title
    Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Previous CDK4/6 i Adjuvant Therapy
    Official Title
    Phase II Clinical Study of Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Prior Adjuvant Therapy With CDK4/6 Inhibitors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This trial is a single-arm study. The purpose of the trial is to evaluate the efficacy and safety of chidamide and fulvestrant in HR+/HER2- breast cancer that has failed prior adjuvant endocrine therapy with CDK4/6 inhibitors.
    Detailed Description
    The study was a single-center, single-arm, open trial design. Twenty-three patients with advanced HR+/HER2- breast cancer who had failed previous adjuvant treatment with CDK4/6 inhibitors in combination with endocrine therapy were treated with fulvestrant and chidamide.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hormone Receptor-positive Advanced Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    chidamide combined with fulvestrant
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    23 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chidamide combined with fulvestrant
    Arm Type
    Experimental
    Arm Description
    chidamide combined with fulvestrant
    Intervention Type
    Drug
    Intervention Name(s)
    chidamide combined with fulvestrant
    Intervention Description
    chidamide combined with fulvestrant
    Primary Outcome Measure Information:
    Title
    ORR
    Description
    The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
    Time Frame
    max 6 months
    Secondary Outcome Measure Information:
    Title
    PFS
    Description
    time to progressive disease (according to RECIST1.1)
    Time Frame
    Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1 years)
    Title
    CBR
    Description
    The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
    Time Frame
    max 6 months
    Title
    DOR
    Description
    Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
    Time Frame
    max 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female, ≥18 years old; ECOG score 0-1; Predicted survival ≥3 months; Patients with locally advanced and/or metastatic breast cancer confirmed by histopathology with positive ER expression and negative ER2 expression; Patients who have relapsed or metastasized during or after CDK4/6 inhibitors combined with endocrine adjuvant therapy and have not received systemic antitumor therapy for the current stage of disease; No previous treatment with fluvestran or use of fluvestran without proven treatment failure; The time interval between non-endocrine therapy should be ≥2 weeks; At least one extracranial measurable lesion as defined by RECIST V1.1 criteria; The functions of vital organs meet the requirements; Fertile subjects must have a negative pregnancy test 7 days before starting treatment and must use an appropriate contraceptive method during treatment and for three months after completion of treatment; The patient is fully informed and voluntarily signs the informed consent. Exclusion Criteria: Prior treatment with any HDAC inhibitors; Known allergy to the tested drug component; inflammatory breast cancer at the time of screening; pia meningeal metastasis confirmed by MRI or lumbar puncture; Central nervous system metastasis confirmed by imaging; To the best of the investigator's judgment, symptomatic visceral disease or any disease load or none is considered optimal Endocrine therapy options are not suitable for endocrine therapy; Inability or unwillingness to swallow medication or receive intramuscular injections; Gastrointestinal insufficiency or gastrointestinal disease (if not controlled) that may significantly affect study drug absorption Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small intestine resection, etc.; Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms in the baseline period need drainage, or use it for the first time Patients with serous cavity drainage within 4 weeks before medication; A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency conditions, Or have a history of organ transplantation; Other malignancies (cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and Thyroid cancer is excluded); had undergone major surgical procedures or significant trauma within 4 weeks prior to the start of treatment, or was expected to undergo major surgery Surgical treatment; Concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with patient completion of the study (e.g. Severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other activities Sexual infection); Inability to understand or follow research instructions and requirements; The researcher decides that it is not suitable to participate in this study

    12. IPD Sharing Statement

    Learn more about this trial

    Combination of Chidamide and Fulvestrant for HR+/HER2- Breast Cancer That Has Failed Previous CDK4/6 i Adjuvant Therapy

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