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
4 other identifiers
observational
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedStudy Start
First participant enrolled
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedJanuary 29, 2026
January 1, 2026
1.7 years
April 12, 2018
January 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Myocardial perfusion reserve index (MPRI)
Will first estimate 95% confidence intervals for each group at each time point as well as for the change from baseline to 3-6-months in each group.
Baseline and 3-6 months
Secondary Outcomes (4)
Myocardial rest myocardial fibrosis burden (T1) and left ventricular ejection fraction (LVEF)
Baseline and 3-6 months
Change in MPRI measures
Baseline to 3-6 months
Accrual rate defined as based on the number of patients who participate compared to the total number of patients approached
Baseline and 3-6 months
Retention rate defined the number of patients who are enrolled and complete both assessments
Baseline and 3-6 months
Study Arms (1)
Diagnostic (stress test)
Within 2 years of initiating anti-estrogen therapy or 2 years after completing chemotherapy, participants undergo a stress test which consists of receiving adenosine IV over 1-5 minutes or regadenoson IV over 2 minutes and then undergoing CMR imaging over 45-60 minutes at baseline, and again 3-6 months later.
Interventions
Undergo CMR imaging
Eligibility Criteria
Adults with stage I-III breast cancer
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Douglas
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 23, 2018
Study Start
June 21, 2018
Primary Completion
March 5, 2020
Study Completion
March 5, 2020
Last Updated
January 29, 2026
Record last verified: 2026-01