NCT02772367招募中不适用
Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- derive iPSs from skin fibroblasts
研究概览
简要总结
The purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. The structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.
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
- •Age greater than 18 years
- •Willing to participate in protocol procedures with signed informed consent
- •Assessment of LVEE via echocardiogram, cardiac MRI, or MUGA
- •Subjects in the cardiotoxicity group (TOX) must meet the following criteria:
- •History of HER2 positive breast cancer (stage I-IV)
- •Prior/current treatment with anthracycline based chemotherapy followed by anti-HER2 directed therapy or anti-HER2 directed therapy alone
- •Assessment of LVEF at baseline prior to initiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA
- •Prior confirmed diagnosis of cardiotoxicity associated with anti-HER2 based therapy, defined as a decrease in LVEF > 10% from baseline to < 53% with symptoms of heart failure (NYHA class II-IV).
- •Subjects in the no cardiotoxicity group (NO-TOX) must meet the following criteria:
- •History of HER2 positive breast cancer (stage I-IV)
- •Completion of planned anthracycline and anti-HER2 therapy, or anti-HER2 therapy alone
- •No symptoms of heart failure (NYHA class II-IV) during and at the end of anthracycline and anti-HER2 therapy
- •Assessment of LVEF at baseline prior to innitiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA
- •Normal LVEF >53% at each assessment during and at the end of trastuzumab therapy.
- •Maximum absolute decrease in LVEF <5% from baseline during and at the end of trastuzumab therapy.
- •LVEF assessment performed at baseline and at least two time points during trastuzumab therapy.
排除标准
- •Unwilling or unable to give skin biopsies
- •Contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator.
- •Known pre-existing CV disease prior to initiation of breast cancer therapy as determined by the investigator, including
- •Obstructive coronary artery disease (stenosis >70%)
- •Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (>30 seconds), ventricular fibrillation, or cardiac arrest
- •Cardiomyopathy (EF <53%)
- •Heart failure (NYHA class II-IV)
- •Valvular heart disease with equal to or greater than moderate stenosis or regurgitation
结局指标
主要结局
derive iPSs from skin fibroblasts
时间窗: 1 day
described by Yamanaka et al with modification using the Millipore STEMCCA excisable polycystronic lentivirus reprogramming kit.2
次要结局
未报告次要终点
研究者
研究点 (1)
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