Overview

Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors

Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
Female
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 of Chidamide in combination with Fulvestrant.Patients included in the trial were advanced breast cancer progressing on first-line aromatase inhibitor + Cyclin-dependent kinases(CDK)4/6i rescue therapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Liaoning Tumor Hospital & Institute
Treatments:
Fulvestrant
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.