Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
The ESPRIT Study: Estrogen Suppression and Perfusion Reserve With Aromatase-Inhibitor Treatment in Premenopausal Women With Breast Cancer
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.
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.
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