Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Estimate the incidence /of Herceptin induced heart failure in our population
研究概览
简要总结
Early identification of patients at risk for cardiotoxicity represent a primary goal for cardiologist and oncologist
From all adjuvant trials echocardiography is ideal for evaluating Left Ventricular function though its operator dependent. The use of other technique such as endomyocardial biopsy, is troublesome in clinical practice
Cardiac magnetic resonance imaging (MRI) have greater reproducibility in evaluating left ventricular ejection fraction (LVEF). This technique provides morphological, functional, perfusion, and viability information in one assessment. It is expensive and time consuming but id the diagnostic method of choice for patients with technically limited images from ECG and in patients with discordant information that is clinically significant from prior tests
详细描述
Current standard of care for patients while on adjuvant trastuzumab is baseline ECHO are as follows:
Patients on one of the above medications should undergo regular monitoring of the heart function during treatment as the following:
- Baseline evaluation of LVEF prior inhibitor of therapy
- Serial assessment of LVEF using the same modality.
There is no clear international guidelines on the frequency and method of LVEF assessment.
Cardiac function is usually measured by using (ECHO) echo cardiography and multiple-gated acquisition (MUGA) The patient should be assessed with the same techniques during treatment to avoid stressing the myocardium by the use of exercise or ionotropic agent, before measuring LVEF to prevent earlier evidence of cardiotoxicity. Changes in the early atrial (E/A) filling ratio reflect ventricular compliance and may predict diastolic dysfunction and so decline in LVEF.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer cases with histopathology prove of invasive carcinoma with HER 2 over expression detected by immunochemical stain and/ or FISH.
- •Age 18 to 80 years old. Patient with above criteria and eligible for Neu adjuvant/ adjuvant /metastatic( Trastuzumab) Herceptin therapy.
- •Normal blood count, liver function test and kidney function.
排除标准
- •Abnormal cardio vascular disease (ex. Heart Failure, Ischemic Heart Disease, post CABG) with EF≤
- •Valvular abnormality with reduced ejection fraction (EF). Recent Myocardiac Infraction / Ischemia Pregnancy or Breast feeding
研究组 & 干预措施
Herceptin
The study will be carried in prospective manner enrolling all patients diagnosed with breast cancer and over expressed human epidermal growth factor receptor 2 (HER2) and they are requiring Trastuzumab Neu adjuvant/ adjuvant /metastatic therapy as per standard care.
干预措施: Herceptin (Drug)
结局指标
主要结局
Estimate the incidence /of Herceptin induced heart failure in our population
时间窗: 3 years
To evaluate the reversibility of damage in patients on long term follow- up for a period of up to three years. To identify the applicability of troponin / cardiac natriuretic peptides (CNPS) as bio marker that can predict the occurrence of clinically significant left ventricular dysfunction. To evaluate the role of MRI in identifying patient at risk to develop cardio toxicity. Determine the frequency of elevated Troponin and B-type natriuretic peptide (BNP) in patient receiving adjuvant herceptin.
次要结局
- Determine the incremental diagnostic value of Trop and BNP in predicting incidence of Hem CMP.(3 years)