NCT05036252
Active, not recruiting
Not Applicable
A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Baseline VO2peak in participants with HER2-positive breast cancer
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •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)
Outcomes
Primary Outcomes
Baseline VO2peak in participants with HER2-positive breast cancer
Time Frame: At baseline
The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction
Study Sites (1)
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