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

NCT ID: NCT05036252

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2026-08-27

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with HER2-positive breast cancer

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.

Cardiopulmonary Exercise Test

Intervention Type: DIAGNOSTIC_TEST

All enrolled participants will undergo a cardiopulmonary exercise test (CPET). The CPET will be conducted using an electronic motorized treadmill with 12-lead ECG monitoring performed by ACSM-certified exercise physiologists.

Echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Resting assessment of LVEF and GLS will be evaluated through Conventional 2D and Doppler echocardiograms will be performed per protocol using a commercially available ultrasound scanner, according to the American Society of Echocardiography (ASE) recommendations for a comprehensive examination.

Echocardiography

Intervention Type: DIAGNOSTIC_TEST

As soon as possible following completion of the CPET, subjects will be placed in the supine position and 2D echocardiographic images will be obtained in the apical 4-/ 3-/2-chamber views.

Interventions

Cardiopulmonary Exercise Test

All enrolled participants will undergo a cardiopulmonary exercise test (CPET). The CPET will be conducted using an electronic motorized treadmill with 12-lead ECG monitoring performed by ACSM-certified exercise physiologists.

Intervention Type: DIAGNOSTIC_TEST

Echocardiogram

Resting assessment of LVEF and GLS will be evaluated through Conventional 2D and Doppler echocardiograms will be performed per protocol using a commercially available ultrasound scanner, according to the American Society of Echocardiography (ASE) recommendations for a comprehensive examination.

Intervention Type: DIAGNOSTIC_TEST

Echocardiography

As soon as possible following completion of the CPET, subjects will be placed in the supine position and 2D echocardiographic images will be obtained in the apical 4-/ 3-/2-chamber views.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CPET

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan - Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

21-271

Identifier Type: -

Identifier Source: org_study_id