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

PRIMARY OBJECTIVES:

I. To describe decrements in left ventricular myocardial microcirculatory perfusion reserve
in premenopausal women treated with an aromatase inhibitor for high-risk hormone
receptor-positive breast cancer and in premenopausal women treated without an aromatase
inhibitor for triple negative breast cancer over three to six months of in the first 24
months on an aromatase inhibitor or after cessation of chemotherapy, respectively.

SECONDARY OBJECTIVES:

I. To describe changes between the cohorts with hormone receptor-positive and triple negative
breast cancer in other measures of cardiovascular function as measured by myocardial rest T1
(myocardial fibrosis burden) and left ventricular ejection fraction (LVEF) measured
noninvasively with cardiovascular magnetic resonance (CMR) imaging over three to six months.

II. To describe the relationship of clinical and demographic variables in relation to their
potential contribution to changes in left ventricular myocardial microcirculatory perfusion
reserve over three to six months in both groups.

III. To study the overall feasibility of accruing and retaining premenopausal women with
stage I-III breast cancer in a trial using adenosine stress CMR to assess myocardial
perfusion reserve (MPR) and other parameters of cardiovascular health.

OUTLINE:

Within 2 years of initiating anti-estrogen therapy or 2 years after completing chemotherapy,
participants undergo a stress test which consists of receiving adenosine intravenously (IV)
over 1-5 minutes or regadenoson IV over 2 minutes and then undergoing CMR imaging over 45-60
minutes at baseline and then 3-6 months later.

After completion of study, participants are followed up at 30 days.

Inclusion Criteria:

- Women who were premenopausal at the time of breast cancer diagnosis; (premenopausal is
defined as per National Comprehensive Cancer Network (NCCN) criteria

- Diagnosed with stage I-III breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Life expectancy of greater than 6 months

- 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)

Exclusion Criteria:

- Women with human epidermal growth factor-2 (HER2) positive breast cancer would be
excluded from this pilot

- Women taking a statin for daily for > 6 months

- 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