Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- difference in LVEF (Left Ventricular Ejection Fraction)
研究概览
简要总结
The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab (patients treated for early breast cancer) is really safe for the heart even years after treatment and if the investigators should use these two treatments concomitantly without additional harm.
详细描述
The investigators know from the studies, that were already published, that for HER2 positive early breast cancer patients in adjuvant treatment concomitant radiotherapy and trastuzumab is safe during the treatment. But there is no study with long term results of cardial function, especially combination of Left ventricular ejection fraction (LVEF) and NT-proBNP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Early breast cancer patients,treated adjuvantly with radiotherapy of the operated breast or thoracic wall and treated concomitantly with trastuzumab.
- •Reviewed many months after treatment, without recurrence of disease.
排除标准
- •Recurrence of disease
结局指标
主要结局
difference in LVEF (Left Ventricular Ejection Fraction)
时间窗: from one to six years from adjuvant radiotherapy for early breast cancer
we will compare LVEF (LVEF 1) measured before treatment with adjuvant Trastuzumab and concomitant Radiotherapy of breast/thoracic wall with LVEF (LVEF 2) measured at follow up (after adjuvant treatment) outpatient examination. We will then compare the difference in LVEF (LVEF 2-LVEF 1) measured in patients treated for left breast cancer with the difference in LVEF (LVEF 2-LVEF 1) measured in patients treated for right breast cancer
次要结局
- occurrence of cardiovascular events over time in both groups (RT for left/right breast)(from 6 months to five years after adjuvant therapy with trastuzumab)