Status:
UNKNOWN
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors
Lead Sponsor:
Liaoning Cancer Hospital & Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The trial used a multicenter, open, single-arm design in which patients were treated with Chidamide combined with Fulvestrant.The primary objective is to evaluate the preliminary efficacy and safety o...
Eligibility Criteria
Inclusion
- age ≥ 18 years, postmenopausal \* female patients;
- histologically or cytologically confirmed hormone receptor positive (ER positive, PR positive or negative), human epidermal growth factor receptor 2 negative # breast cancer patients;
- the disease before enrollment is overall unresectable locally advanced or metastatic breast cancer, and at least one measurable lesion or no measurable lesion and bone metastasis alone patients;
- for locally advanced or metastatic breast cancer, previous progression by first-line aromatase inhibitors combined with Cyclin-dependent kinases（CDK）4/6 inhibitors;
- the total number of regimens regardless of rescue therapy or adjuvant therapy before enrollment is ≤ 3, of which the number of rescue chemotherapy regimens is ≤ 1;
- Eastern Collaborative Oncology Group（ECOG） score 0-1;
- absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;
- expected survival time ≥ 3 months;
- Voluntarily participate in this clinical trial and sign the written informed consent form
Exclusion
- no measurable lesions (except simple bone metastasis), such as pleural or pericardial exudate, ascites, etc.;
- underwent major surgical procedures or significant trauma before enrollment, or patients are expected to undergo major surgical treatment;
- Patients who have previously been treated with fulvestrant or histone deacetylase inhibitors (including romidepsin, vorinostat), but have received only one cycle (≤ 2 times, d1, d15, respectively) of fulvestrant within 28 days (before enrollment) are allowed;
- known to have a history of allergy to the drug components of this protocol;
- the presence of brain (membrane) metastasis during the screening period;
- a history of immunodeficiency, including HIV test positive, or suffering from other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
- uncontrolled important cardiovascular disease;
- abnormal liver function \[total bilirubin \> 1.5 times the upper limit of normal; alanine aminotrans（ALT）/aspartate aminotransferase（AST） \> 2.5 times the upper limit of normal in patients without liver metastasis, alanine aminotrans（ALT）/aspartate aminotransferase（AST） \> 5 times the upper limit of normal in patients with liver metastasis\], abnormal renal function (serum creatinine \> 1.5 times the upper limit of normal);
- pregnant, lactating female patients or women of childbearing potential baseline pregnancy test positive; or during the study and the last dose of at least 8 to take effective contraceptive measures in subjects of childbearing age;
- According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (such as: severe hypertension, diabetes, thyroid disease, active infection, etc.);
- History of definite neurological or psychiatric disorders, including epilepsy or dementia;
- Unsuitable for participation in the study as judged by the investigator.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05191914
Start Date
February 7 2022
End Date
December 30 2022
Last Update
January 14 2022
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