Breast Cancer Clinical Trial
Official title:
A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy
NCT number | NCT05036252 |
Other study ID # | 21-271 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 27, 2021 |
Est. completion date | August 27, 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 27, 2024 |
Est. primary completion date | August 27, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan - Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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