Early Detection and Prediction of Chemotherapy Induced Cardiac Toxicity in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents
研究概览
简要总结
The goal of this clinical research study is to learn whether different ways of viewing echocardiogram pictures along with blood tests can help to see heart-related side effects of chemotherapy and trastuzumab earlier than the usual tests.
详细描述
Echocardiogram:
Because of the heart-related side effects of chemotherapy and trastuzumab, your regular doctor will monitor your heart's function as part of your routine care. You will have echocardiograms performed before you begin treatment, and then every 3 months. An echocardiogram uses sound waves to check your heart's health.
If you decide to take part in this study, researchers will take several additional pictures of your heart during each of your regularly scheduled echocardiograms. The additional pictures will make the procedure take about 5-10 minutes longer than the regular echocardiogram. These pictures will be viewed in a different way than the standard echocardiogram pictures. Researchers hope viewing the pictures this way can help researchers to find heart problems earlier than the usual tests.
Blood Tests:
Blood (about 4 teaspoon each time) will be drawn during the routine blood draw that occurs closest to the regularly scheduled echocardiograms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •HER-2 positive breast cancer
- •Scheduled to receive Herceptin infusion therapy after exposure to anthracycline-based chemotherapy in one of the following manners: Adjuvant or neoadjuvant treatment with anthracycline-based chemotherapy preceded or followed by Herceptin infusion therapy, Herceptin monotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy, Herceptin in combination with non-anthracycline chemotherapy in patients with metastatic disease previously treated with anthracycline-based chemotherapy
- •Normal baseline left ventricular ejection fraction.
排除标准
- •Pre-existing cardiomyopathy (Left Ventricular Ejection Fraction (LVEF) < 50%)
- •Other contraindication to Herceptin therapy
结局指标
主要结局
Predictors of cardio-toxicity in female patients with breast cancer exposed to trastuzumab +/- previous anthracycline agents
时间窗: Baseline to 12 months
Identification of heart-related side effects of chemotherapy and trastuzumab using echocardiogram pictures plus blood tests.
次要结局
未报告次要终点