An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- LVEF Results
研究概览
简要总结
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).
At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment.
At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Histologically confirmed early stage HER2-positive breast cancer
- •Planned trastuzumab therapy for early stage breast cancer
- •≥18 years of age
- •Able to provide verbal consent
- •Normal LVEF (>53%) before trastuzumab therapy
排除标准
- •Contraindication to transthoracic echocardiography or MUGA
结局指标
主要结局
LVEF Results
时间窗: Baseline to 1 year
Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%).
LVEF Results
时间窗: Baseline to 1 year
Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%).
次要结局
- Rates of Trastuzumab Delay and Discontinuation(1 year)
- Referral to Cardiology(1 year)
- Rate of Cardiac Events(1 year)
- Referral to Cardiology(1 year)
- Rates of Trastuzumab Delay and Discontinuation(1 year)