轻度心脏毒性 HER2 阳性乳腺癌女性的心肺运动试验研究
接受 HER2 靶向治疗的左心室收缩功能障碍患者心肺运动试验的初步研究
The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
New York
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New York、New York、美国、10021
- Memorial Sloan - Kettering Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Potential research participants will be identified by a member of the participant's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK). If the investigator is a member of the treatment team, s/he will screen their potential participant's medical records for suitable research study participants and discuss with the subject their potential for enrolling in the research study.
描述
Inclusion Criteria:
- Age ≥ 18 years
- Female
- Diagnosed with a HER2-positive solid tumor (stage I-IV)
- Left ventricular dysfunction prior to the start of HER2-targeted therapy, defined by a LVEF < 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with HER2-targeted therapy, defined by an absolute decrease in LVEF ≥ 10% from pre-treatment to < 53%
- Planning to undergo treatment with HER2-targeted therapy (e.g. trastuzumab, pertuzumab, or ado-trastuzumab) for a minimum of 3 months (i.e. 4 cycles administered every 3 weeks).
- Willing and able to comply with the requirements of the protocol
Exclusion Criteria:
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Symptomatic heart failure (New York Heart Association Class III or IV)
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Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
- Acute myocardial infarction (within 30 days of any planned study procedures),
- Unstable angina
- Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
- Symptomatic severe aortic stenosis
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
- Thrombosis of lower extremities (within 3 months of any planned study procedures)
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Room air desaturation at rest ≤ 85%
- Respiratory failure
- Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- Mental impairment leading to inability to cooperate.
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Enrollment onto any other interventional investigational study
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Inability to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Participants with HER2-positive breast cancer
Participants with HER2-positive breast cancer who have developed mild cardiotoxicity during HER2-targeted therapy, defined by a decline in LVEF > 10% to < 53% without symptoms of clinical heart failure (NYHA class III or IV), will be eligible for participation in this study. |
All enrolled participants will undergo a cardiopulmonary exercise test (CPET). The CPET will be conducted using an electronic motorized treadmill with 12-lead ECG monitoring performed by ACSM-certified exercise physiologists.
其他名称：
Resting assessment of LVEF and GLS will be evaluated through Conventional 2D and Doppler echocardiograms will be performed per protocol using a commercially available ultrasound scanner, according to the American Society of Echocardiography (ASE) recommendations for a comprehensive examination. As soon as possible following completion of the CPET, subjects will be placed in the supine position and 2D echocardiographic images will be obtained in the apical 4-/ 3-/2-chamber views. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Baseline VO2peak in participants with HER2-positive breast cancer
大体时间：At baseline
|
The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction |
At baseline
|
合作者和调查者
调查人员
- 首席研究员：Anthony Yu, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 21-271
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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研究美国 FDA 监管的设备产品
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