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Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer

Primary Purpose

Hormone Receptor-positive Advanced Breast Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
chidamide,fulvestrant
Sponsored by
The First Affiliated Hospital with Nanjing Medical 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: Age ≥ 18 years, female. Both postmenopausal and premenopausal for hormone receptor positive patients, but premenopausal patients need to be given concomitant ovarian function suppression (OFS) therapy (criteria for menopause: "Judgment Criteria for Menopause after Adjuvant Therapy and Consensus on Clinical Application of Aromatase Inhibitors for Premenopausal Female Breast Cancer Patients in China"). Patients with HR-positive (ER-positive, PR-positive or negative) and HER2-negative breast cancer confirmed by histopathology, defined as follows. Pre-enrollment disease status of non-surgically resectable locally advanced or metastatic breast cancer. At least one extracranial measurable lesion as defined by RECIST V1.1 criteria or bone metastases alone. Progress after previous treatment with CDK4/6 inhibitor combined with any aromatase inhibitor (after previous treatment with CDK4/6 inhibitor combined with aromatase inhibitor, you can enter the study directly or re-enter the group after chemotherapy); ; The total number of previous rescue treatments is ≤3; Previously received rescue chemotherapy ≤1 line; Time interval from the last treatment: (a) If the last treatment is endocrine therapy, it needs ≥2 weeks; (b) If the last treatment is chemotherapy, it needs ≥4 weeks; ECOG PS score: 0-1. Organ function meets the requirement. expected survival ≥ 3 months. Subjects of childbearing potential need to have a negative pregnancy test within 7 days prior to initiation of treatment and must use an appropriate method of contraception during treatment and for three months after completion of treatment. Patients are fully informed and voluntarily sign an informed consent form. Exclusion Criteria: Prior treatment with any HDAC inhibitor or fulvestrant. known hypersensitivity to the drug components of this trial. have inflammatory breast cancer at the time of screening clinical evidence or history of central nervous system metastases (CS) and/or carcinomatous meningitis, soft meningeal disease inability or unwillingness to swallow medications or receive intramuscular injections have gastrointestinal insufficiency or gastrointestinal disease that can significantly interfere with the absorption of study drug (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) History of immunodeficiency, including testing positive for HIV, or having other acquired or congenital immunodeficiency disorders, or a history of organ transplantation. other malignancies (except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid cancer) within the previous 5 years or concurrently having undergone a major surgical operation or significant trauma within 4 weeks prior to initiation of treatment, or where the patient is expected to undergo major surgical treatment Inability to understand or follow study guidelines and requirements. Those who are judged by the investigator to be unsuitable for participation in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    chidamide combined with fulvestrant

    Arm Description

    fulvestrant

    Outcomes

    Primary Outcome Measures

    Progression Free Survival (PFS)
    Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.

    Secondary Outcome Measures

    Objective Response Rate (ORR)
    The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
    clinical benefit rate(CBR)
    Defined as the percentage of patients who achieved complete remission (CR), partial remission (PR) and stable disease (SD) for ≥24 weeks as a percentage of the total number of patients in the analysis set.
    The Number of Participants Who Experienced Adverse Events (AE)
    Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    April 12, 2023
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05808582
    Brief Title
    Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer
    Official Title
    Multicenter, Single-arm, Open Clinical Study of Chidamide in Combination With Fulvestrant in HR+/HER2-advanced Breast Cancer That Has Failed Prior CDK4/6 Inhibitor Combined With Aromatase Inhibitor Therapy
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical 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
    evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+ABC
    Detailed Description
    This trial is a single-arm study. Designed to evaluate the efficacy and safety of chidamide combined with fulvestrant for HR+/HER2- advanced breast cancer that has failed previous CDK4/6 inhibitor combined with aromatase inhibitor therapy

    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
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chidamide combined with fulvestrant
    Arm Type
    Experimental
    Arm Description
    fulvestrant
    Intervention Type
    Drug
    Intervention Name(s)
    chidamide,fulvestrant
    Other Intervention Name(s)
    Regular Visits
    Intervention Description
    chidamide combined with fulvestrant
    Primary Outcome Measure Information:
    Title
    Progression Free Survival (PFS)
    Description
    Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate (ORR)
    Description
    The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
    Time Frame
    2 years
    Title
    clinical benefit rate(CBR)
    Description
    Defined as the percentage of patients who achieved complete remission (CR), partial remission (PR) and stable disease (SD) for ≥24 weeks as a percentage of the total number of patients in the analysis set.
    Time Frame
    2 years
    Title
    The Number of Participants Who Experienced Adverse Events (AE)
    Description
    Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years, female. Both postmenopausal and premenopausal for hormone receptor positive patients, but premenopausal patients need to be given concomitant ovarian function suppression (OFS) therapy (criteria for menopause: "Judgment Criteria for Menopause after Adjuvant Therapy and Consensus on Clinical Application of Aromatase Inhibitors for Premenopausal Female Breast Cancer Patients in China"). Patients with HR-positive (ER-positive, PR-positive or negative) and HER2-negative breast cancer confirmed by histopathology, defined as follows. Pre-enrollment disease status of non-surgically resectable locally advanced or metastatic breast cancer. At least one extracranial measurable lesion as defined by RECIST V1.1 criteria or bone metastases alone. Progress after previous treatment with CDK4/6 inhibitor combined with any aromatase inhibitor (after previous treatment with CDK4/6 inhibitor combined with aromatase inhibitor, you can enter the study directly or re-enter the group after chemotherapy); ; The total number of previous rescue treatments is ≤3; Previously received rescue chemotherapy ≤1 line; Time interval from the last treatment: (a) If the last treatment is endocrine therapy, it needs ≥2 weeks; (b) If the last treatment is chemotherapy, it needs ≥4 weeks; ECOG PS score: 0-1. Organ function meets the requirement. expected survival ≥ 3 months. Subjects of childbearing potential need to have a negative pregnancy test within 7 days prior to initiation of treatment and must use an appropriate method of contraception during treatment and for three months after completion of treatment. Patients are fully informed and voluntarily sign an informed consent form. Exclusion Criteria: Prior treatment with any HDAC inhibitor or fulvestrant. known hypersensitivity to the drug components of this trial. have inflammatory breast cancer at the time of screening clinical evidence or history of central nervous system metastases (CS) and/or carcinomatous meningitis, soft meningeal disease inability or unwillingness to swallow medications or receive intramuscular injections have gastrointestinal insufficiency or gastrointestinal disease that can significantly interfere with the absorption of study drug (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) History of immunodeficiency, including testing positive for HIV, or having other acquired or congenital immunodeficiency disorders, or a history of organ transplantation. other malignancies (except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid cancer) within the previous 5 years or concurrently having undergone a major surgical operation or significant trauma within 4 weeks prior to initiation of treatment, or where the patient is expected to undergo major surgical treatment Inability to understand or follow study guidelines and requirements. Those who are judged by the investigator to be unsuitable for participation in this study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer

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