Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer

Completed

Conditions studied: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Premenopausal, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

In brief

This pilot trial studies how well a stress test works in detecting heart damage in premenopausal women with stage I-III breast cancer. Giving a stress test with adenosine or regadenoson and cardiovascular magnetic resonance imaging may help doctors detect heart damage caused by breast cancer treatments including chemotherapy and aromatase inhibitors.

Key facts

Study ID

NCT03505736

Run by

Wake Forest University Health Sciences

People needed

25

Starts

2018-06-21

Expected to finish

2020-03-05

Last updated by the study team

2026-01-29

Who can join

Age: any, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who were premenopausal at the time of breast cancer diagnosis; (premenopausal is defined as per National Comprehensive Cancer Network (NCCN) criteria
• Breast cancer treatment is within three years of initiating anti-estrogen therapy and includes medically or surgically induced menopause (HR-positive tumor) or three years of completing chemotherapy (HR-negative tumor)
• Diagnosed with stage I-III breast cancer OR with metastatic breast cancer and receiving ovarian suppression function and aromatase inhibitors as their first non-chemotherapy regimen in the metastatic setting (can include CDK inhibitor with aromatase inhibitor)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative)

You may not qualify if…

• Women with human epidermal growth factor-2 (HER2) positive breast cancer would be excluded from this pilot given the confounding issue of the cardiotoxicity associated with HER2-directed therapies.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine (or regadenoson for those with history of asthma or chronic obstructive pulmonary disease [COPD])
• Those with contraindications for MRI such as some breast expanders, ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; a pregnancy test is required, unless the patient has undergone either a bilateral oophorectomy, hysterectomy or both
• Coronary revascularization in the past 6 months or known severe multi-vessel coronary artery disease (CAD) previously determined to be not amenable to mechanical intervention
• Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.