Cardiotoxicity of Cancer Therapy 2: Mechanisms, Predictors, and Social Determinants of Health in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
This is an observational study for patients with breast cancer that will be treated with doxorubicin (Adriamycin) and/or trastuzumab (Herceptin). The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 15 years.
详细描述
The investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines and/or trastuzumab to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine whether associations between SDOH and cardiotoxicity risk differ according to race. Patients will be followed with serial echo, blood draw, and surveys every 3 months for the first year, then annually for two years. After 3 years following start of cancer therapy, patients will have study visits every other year for up to 15 years.
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
- •Women older than 18 years of age
- •Breast cancer with treatment plan that includes doxorubicin and/or trastuzumab
- •Ability to provide written informed consent
排除标准
- •Pregnancy at enrollment
- •Inability or unwillingness to provide consent
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (LVEF)
时间窗: through study completion (expected to be 15 years)
Absolute change in LVEF by echocardiogram at follow-up
次要结局
- Change in Relative LV Wall Thickness(through study completion (expected to be 15 years))
- Change in Ventricular-Arterial Coupling(through study completion (expected to be 15 years))
- Change in patient reported quality of life(through study completion (expected to be 15 years))
- Change in NTproBNP(through study completion (expected to be 15 years))
- Change in high-sensitivity troponin (hsTnT)(through study completion (expected to be 15 years))
- Change in Longitudinal Strain(through study completion (expected to be 15 years))
- Change in Diastolic function(through study completion (expected to be 15 years))
- Change in LV Twist(through study completion (expected to be 15 years))
- Cancer therapy-related cardiac dysfunction (CTRCD)(through study completion (expected to be 15 years))
- Symptomatic Heart Failure (HF)(through study completion (expected to be 15 years))
- Change in Circumferential Strain(through study completion (expected to be 15 years))
- Change in LV Torsion(through study completion (expected to be 15 years))
- Change in patient reported fatigue(through study completion (expected to be 15 years))
- Change in patient reported activity level(through study completion (expected to be 15 years))
- Change in Left Ventricular (LV) Mass(through study completion (expected to be 15 years))