Late Cardiac Evaluation of the Three Arm Belgian Trial A Phase III Randomized Trial Involving Node-positive Early Breast Cancer Patients With a Long Median Follow-up (~ 15 Years)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Late cardiac toxicity
研究概览
简要总结
Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (~ 15 years)
OBJECTIFS
Primary:
• To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial
Secondary:
- To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients;
- To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for:
- left ventricular diastolic function assessed by Echo
- exercise capacity assessed by 6-minute walk test (6MWT)
- cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI
- serum cardiac biomarkers (BNP and TNT)
- patient-reported cardiac symptoms
- patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment
- cognitive function, functional autonomy, and psychological distress
详细描述
The primary objective of this study is to compare the incidence of cardiac events [(defined as asymptomatic systolic dysfunction (LVEF < 50%, asymptomatic NYHA I) or symptomatic heart failure NYHA class II-IV either by Echo and/or by clinical exam (LVEF < 50% and heart failure symptoms)] between anthracycline and non-anthracycline chemotherapy treated node-positive breast cancer patients in a long-term follow-up. We will define a binary status for each patient: no cardiac event / one or more cardiac events. Analysis of the primary endpoint will involve a comparison of the CMF-treated patients versus the pooled anthracycline treated patients (EC and HEC). If a significant difference is detected, all paired comparisons will also be performed for the primary endpoint (CMF versus EC, CMF versus HEC, EC versus HEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Alive, free of any recurrence, Not lost to follow-up
- •Last workup should be no older than 1 year to exclude relapses. If this is older than 1 year, a new workup (PE, blood tests and MMG) will be performed prior to the entry in this study
- •Patients previously diagnosed with CHF who are free of recurrence will also be invited to participate, if there is no contra-indication
- •Patients should be able to perform the prescribed assessments
排除标准
- •Breast cancer recurrence
- •Unwilling to perform exams as per protocol
结局指标
主要结局
Late cardiac toxicity
时间窗: Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)
The primary objective of this study is to compare the incidence of cardiac events \[(defined as asymptomatic systolic dysfunction (LVEF \< 50%, asymptomatic NYHA I) or symptomatic heart failure NYHA class II-IV either by Echo and/or by clinical exam (LVEF \< 50% and heart failure symptoms)\] between anthracycline and non-anthracycline chemotherapy. Analysis of the primary endpoint will involve a comparison of the CMF-treated patients versus the pooled anthracycline treated patients (EC and HEC).
次要结局
- Late cardiac and cognitive toxicity(Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years))