NCT05191914Unknown4 期
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to Cyclin-dependent Kinases（CDK）4/6 Inhibitors
Liaoning Tumor Hospital & Institute0 个研究点目标入组 20 人开始时间: 2022年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
chidamide + fulvestrant
Experimental
干预措施: Chidamide+ Fulvestrant (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to approximately 16 months
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.
次要结局
- Clinical Benefit Rate (CBR)(Up to approximately 16 months)
- Duration of Response (DOR)(Up to approximately 16 months)
- Overall Response Rate (ORR)(Up to approximately 16 months)
- Overall Survival (OS)(Up to approximately 38 months)
研究者
Tao Sun
Director
Liaoning Tumor Hospital & Institute
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