Clinical Trials Directory

Trials / Completed

CompletedNCT03505736

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

The ESPRIT Study: Estrogen Suppression and Perfusion Reserve With Aromatase-Inhibitor Treatment in Premenopausal Women With Breast Cancer

Status
Completed
Phase
—
Study type
Observational
Enrollment
25 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
Female
Age
55 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAdenosineGiven IV
PROCEDUREMagnetic Resonance ImagingUndergo CMR imaging
DRUGRegadenosonGiven IV
PROCEDUREStress Management TherapyUndergo stress test

Timeline

Start date
2018-06-21
Primary completion
2020-03-05
Completion
2020-03-05
First posted
2018-04-23
Last updated
2026-01-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03505736. Inclusion in this directory is not an endorsement.