Stress Test in Detecting Heart Damage in Premenopausal Women With Stage I-III Breast Cancer
NCT ID: NCT03505736
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
25 participants
OBSERVATIONAL
2018-06-21
2020-03-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
NCT01831076
Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer
NCT02598557
Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole
NCT00316836
Cardiac Outcomes With Near-Complete Estrogen Deprivation
NCT05309655
Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
NCT01196936
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Adenosine
Given IV
Magnetic Resonance Imaging
Undergo CMR imaging
Regadenoson
Given IV
Stress Management Therapy
Undergo stress test
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Adenosine
Given IV
Magnetic Resonance Imaging
Undergo CMR imaging
Regadenoson
Given IV
Stress Management Therapy
Undergo stress test
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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)
Exclusion Criteria
* 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
55 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emily Douglas
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-00588
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 98118
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00049171
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.