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

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• 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.

Egyéb

• Enrollment onto any other interventional investigational study
• Inability to provide informed consent

• 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