NCT00968682已完成不适用
Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 14
- 主要终点
- Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers
研究概览
简要总结
RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may also help doctors predict which patients will develop heart dysfunction.
PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart dysfunction in women with breast cancer treated with trastuzumab.
详细描述
OBJECTIVES:
Primary
- To prospectively evaluate whether an increase in cardiac biomarker levels can predict cardiac dysfunction in women with HER2/neu-positive breast cancer treated with trastuzumab as curative intent.
Secondary
- To develop a predictive model for use in this patient population based on the most accurate and sensitive combination of biomarkers.
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
- 未提供
排除标准
- •Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
- •Evidence of metastatic disease.
- •Patients with uncontrolled hypertension (sustained systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
- •Prior anthracycline or Trastuzumab therapy.
- •Inability to give informed consent for any reason.
结局指标
主要结局
Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers
时间窗: End of trial
Cardiac biomarker levels in predicting cardiac dysfunction
时间窗: End of trial
次要结局
未报告次要终点
研究者
研究点 (14)
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