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

  • STATUS
    Recruiting
  • End date
    Aug 27, 2023
  • participants needed
    30
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 15 October 2022
pertuzumab
HER2
trastuzumab
erbb2
her2/neu-positive breast cancer

Summary

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.

Details
Condition 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
Treatment Echocardiography, cardiopulmonary exercise test, echocardiogram
Clinical Study IdentifierNCT05036252
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on15 October 2022

Eligibility

Yes No Not Sure

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
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