ACTRN12624000148572尚未招募未知
The Effects of 3 monthly versus 6 monthly Cardiac Monitoring on Left Ventricular Ejection Fraction in Patients Treated with HER2-Directed Therapies for Breast Cancer
Monash Health Department of Oncology0 个研究点目标入组 140 人开始时间: 2024年2月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Capable of providing written informed consent and willing to adhere to all protocol requirements
- •Histologically confirmed HER2-positive breast cancer, as confirmed on immunohistochemistry (IHC) or fluorescence in situ hybridisation; Participants with IHC 1+ or 2+ results, also known as HER2-low cancer, are allowed to participate if they are planned for treatment with HER2-directed therapies
- •Planned for or commenced treatment with HER2-directed therapy for less than 3 months, which include monotherapy or combination therapy with any of the following agents - Trastuzumab, Pertuzumab, Trastuzumab emtansine, Trastuzumab deruxtecan, Neratinib, Lapatinib
排除标准
- •Unable to provide written informed consent
- •Unable or unwilling to adhere to all protocol requirements
- •Commenced current treatment with HER2-directed therapy for 3 months or longer
- •History of left ventricular dysfunction or heart failure with reduced ejection fraction, defined as left ventricular ejection fraction of <50% (this includes patients with left ventricular dysfunction identified on baseline screening echocardiogram or previous left ventricular dysfunction that recovered with cardioprotective medications)
- •History of left ventricular dysfunction during previous treatment with HER2-directed therapies
- •History of severe valvular heart disease
- •Poor imaging quality on baseline screening echocardiogram limiting interpretation of baseline and potentially future echocardiogram results
- •Severe uncontrolled tachyarrhythmia
- •History of ventricular tachycardia or ventricular fibrillation
- •History of permanent pacemaker or implantable cardiac defibrillator implantation
- •Prognostic factors associated with an expected survival less than 12 months as per treating clinician discretion.
研究者
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