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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05036252

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Diagnostic Test: Cardiopulmonary Exercise Test Diagnostic Test: Echocardiogram Diagnostic Test: Echocardiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pilot Study of Cardiopulmonary Exercise Testing in HER2-Positive Breast Cancer Patients With Mild Cardiotoxicity

Actual Study Start Date :

Aug 27, 2021

Anticipated Primary Completion Date :

Aug 27, 2023

Anticipated Study Completion Date :

Aug 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: 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. Other Names: CPET 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. 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.

Arm

Intervention/Treatment

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.

Diagnostic Test: 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.

Other Names:

CPET

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.

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.

Outcome Measures

Primary Outcome Measures

Baseline VO2peak in participants with HER2-positive breast cancer [At baseline]
The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive breast cancer and mild cardiotoxicity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Female
Diagnosed with HER2-positive breast cancer (stage I-IV)
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 additional 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:

LVEF < 40%
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