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

Breast Cancer Clinical Trial

Official title:

A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036252
• Other study ID #: 21-271
• Status: Recruiting
• Start date: August 27, 2021
• Est. completion date: August 27, 2024

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Anthony Yu, MD
• Phone: 212-639-7932
• Email: yua3[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 27, 2024
• Est. primary completion date: August 27, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline VO2peak in participants with HER2-positive breast cancer	The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction	At baseline

External Links

•   Memorial Sloan Kettering Cancer Center