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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Echocardiography; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiopulmonary Exercise Test

Study type: Observational

Funder types: Other

Identifiers

NCT05036252

21-271

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Participants with HER2-positive breast cancer

Description:

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.

Treatment:

Diagnostic Test: Cardiopulmonary Exercise Test

Diagnostic Test: Echocardiogram

Diagnostic Test: Echocardiography