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

Active, not recruiting

• Conditions: HER2-positive Breast Cancer; Breast Cancer Stage IV; Cardiotoxicity; HER2-positive Metastatic Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer; Breast Cancer Stage I
• Interventions: Diagnostic Test: Cardiopulmonary Exercise Test; Diagnostic Test: Echocardiogram; Diagnostic Test: Echocardiography

• Registration Number: NCT05036252
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-27
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-08-27
• Study Completion: 2025-08-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with HER2-positive breast cancer	Echocardiogram	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.
Participants with HER2-positive breast cancer	Echocardiography	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.
Participants with HER2-positive breast cancer	Cardiopulmonary Exercise Test	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.

Primary Outcome Measures

Name	Time	Method
Baseline VO2peak in participants with HER2-positive breast cancer	At baseline	The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction

Trial Locations

Locations (1)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States