Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.
详细描述
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Female aged ≥ 18 years
- •Pathologically confirmed HER2-positive breast cancer
- •Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab
- •Baseline echocardiogram should be performed before starting trastuzumab
- •Cumulative anthracycline dose ≤ 300mg/m2
- •Written informed consent to participate in the study
排除标准
- •History of hypersensitivity or alllergic reaction to the study medication
- •Metastatic breast cancer
- •Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics
- •Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) < 12 months before enrollment
- •Pregnancy or breast feeding
- •Baseline systolic pressure < 90mmHg
- •Cumulative anthracycline dose > 300mg/m2
- •Serious concurrent illness
研究组 & 干预措施
Conventional Cardiac intervention
Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.
干预措施: Candesartan (Drug)
Early Cardiac intervention
Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.
干预措施: Candesartan (Drug)
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: at months 3,6,9,12,18
Maximum change in LVEF
次要结局
- Overt chemotherapy induced cardiotoxicity(any time)
- Changes in cardiac biomarker(at months 3,6,9,12,18)
研究者
Yeon Hee Park
Professor, MD, PhD
Samsung Medical Center