Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy

Conditions
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Breast Cancer, HER2-positive Breast Cancer, HER2-positive Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Stage IV, Cardiotoxicity

Intervention / Treatment
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* Diagnostic Test: Cardiopulmonary Exercise Test
* Diagnostic Test: Echocardiogram
* Diagnostic Test: Echocardiography


Participation Criteria
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Eligibility Criteria
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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: Symptomatic heart failure (New York Heart Association Class III or IV) 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. Enrollment onto any other interventional investigational study Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with HER2-positive breast cancer<br>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. | Diagnostic Test: Cardiopulmonary Exercise Test<br>* 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.<br>* Other names: CPET;Diagnostic Test: Echocardiogram<br>* 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.<br>Diagnostic Test: Echocardiography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline VO2peak in participants with HER2-positive breast cancer | The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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21-271, HER2-positive breast cancer, cardiotoxicity, HER2-targeted therapy, Breast cancer, Memorial Sloan Kettering Cancer Center