Early Detection of Chemotherapy-related Cardiomyopathy in Patients With Breast Cancer Using Cardiac Magnetic Resonance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Composite endpoint of cardiac condition
研究概览
简要总结
Breast cancer is the most common cancers among women worldwide.Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. The investigators will focus on the cardiotoxicity of pyrotinib and apatinib which belong to the new tyrosine kinase inhibitors in respective chemotherapy among more subjects.
详细描述
Breast cancer is the most common cancers among women worldwide. Although chemotherapy and surgery have greatly improved the survival rate, most types of chemotherapy have been reported to have varying degrees of cardiotoxicity. We have focused on the field of chemotherapy-related cardiomyopathy. Using the unified magnetic resonance sequences and parameters, effect of chemotherapeutic drugs on the myocardium are studies. Our team's previous pilot study has found that chemotherapy-related cardiomyopathy (CMP) may be predicted within one week after chemotherapy initiation. The specific intervention timing, and the sensitivity and specificity of the early screening indicators are to be explored. At the same time, in patients with human epidermalgrowth factor receptor-2-positive breast cancer, our team observed the change of blood pressure, exercise tolerance and myocardial structure, function and tissue characteristics in patients who used tyrosine kinase inhibitors (pyrotinib and apatinib). This is a supplement to the existing drug knowledge. We are planning to further explore whether it is related to the patient's pre-existing cardiovascular diseases, drug type, dose or dosing. There are no published data addressing the above two research areas. The overall goal is to explore the commonness and specificity of myocardial changes after chemotherapy in breast cancer patients and to predict the development of CMP through multimodality imaging and clinical indices. We aim to propose the CMP time window in respective chemotherapy among more subjects.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18-70 years old.
- •Invasive breast cancer confirmed by Pathology
- •Left ventricular ejection fraction ≥ 50%
- •Having not received any prior systemic anti-cancer therapy for advanced disease
- •an Eastern Cooperative Oncology Group（ECOG） performance status 0-1
- •Providing written informed consent
- •Inclusion Criteria for Control group:
- •Absence of known systemic diseases
- •Normal examinations
- •Age between 18-70 years old.
- •Providing written informed consent
排除标准
- •Age <18 years old or >70 years old
- •Documented coronary artery disease or prior angiography for coronary artery disease (>50% stenosis).
- •Patients with bilateral invasive breast cancers.
- •Patients with metastasis of breast cancer confirmed by imaging or pathology
- •Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate < 30 ml/min/1.73 m2.
结局指标
主要结局
Composite endpoint of cardiac condition
时间窗: change between 1 and 6 months after treatment
Compose of ejection fraction (%)
Composite endpoint of quantitative fibrosis assessment
时间窗: change between 1 and 6 months after treatment
Compose of percentage of extracellular volume (%) and positive rate of late gadolinium enhancement (%).
Exercise tolerance
时间窗: change between 1 and 6 months after treatment
6 minutes walking test
次要结局
未报告次要终点