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Trial Title:
Chidamide Combined With Fulvestrant for HR+/HER2-advanced Breast Cancer
NCT ID:
NCT05808582
Condition:
Hormone Receptor-positive Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
chidamide，fulvestrant
Description:
chidamide combined with fulvestrant
Arm group label:
chidamide combined with fulvestrant
Other name:
Regular Visits
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, female.
2. 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").
3. Patients with HR-positive (ER-positive, PR-positive or negative) and HER2-negative
breast cancer confirmed by histopathology, defined as follows.
4. Pre-enrollment disease status of non-surgically resectable locally advanced or
metastatic breast cancer.
5. At least one extracranial measurable lesion as defined by RECIST V1.1 criteria or
bone metastases alone.
6. 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;
7. ECOG PS score: 0-1.
8. Organ function meets the requirement.
9. expected survival ≥ 3 months.
10. 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.
11. Patients are fully informed and voluntarily sign an informed consent form.
Exclusion Criteria:
1. Prior treatment with any HDAC inhibitor or fulvestrant.
2. known hypersensitivity to the drug components of this trial.
3. have inflammatory breast cancer at the time of screening
4. clinical evidence or history of central nervous system metastases (CS) and/or
carcinomatous meningitis, soft meningeal disease
5. inability or unwillingness to swallow medications or receive intramuscular
injections
6. 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)
7. History of immunodeficiency, including testing positive for HIV, or having other
acquired or congenital immunodeficiency disorders, or a history of organ
transplantation.
8. other malignancies (except cured basal cell carcinoma of the skin, cervical
carcinoma in situ and thyroid cancer) within the previous 5 years or concurrently
9. 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
10. Inability to understand or follow study guidelines and requirements.
11. Those who are judged by the investigator to be unsuitable for participation in this
study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
September 1, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05808582
