RECRUITING

Cardiac Outcomes With Near-Complete Estrogen Deprivation

Conditions

Breast Cancer Triple Negative Breast Cancer Cardiovascular Complications

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to understand what effect near complete estrogen deprivation (NCED) therapy has on the heart in breast cancer patients. Investigators want to understand if NCED changes how the heart works.

Official Title

The Cardiac Outcomes With Near-Complete Estrogen Deprivation (CROWN) Study

Quick Facts

Study Start:2022-09-02

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05309655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine * Active wheezing. * Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices, or some breast expanders. * 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. Because some methods of birth control are not 100% reliable, 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 previously determined to be not amendable to mechanical intervention. * Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization * Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients. * Men with breast cancer. * Known chronic renal insufficiency or chronic electrolyte abnormalities as determined by the treating physician.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to adenosine
* Active wheezing.
* Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices, or some breast expanders.
* 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. Because some methods of birth control are not 100% reliable, 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 previously determined to be not amendable to mechanical intervention.
* Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization
* Allergy or prior sensitivity to gadolinium or other contrasting agents or their excipients.
* Men with breast cancer.
* Known chronic renal insufficiency or chronic electrolyte abnormalities as determined by the treating physician.

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

336-713-5435

jriley@wakehealth.edu

Principal Investigator

Alexandra Thomas, MD

PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Study Locations (Sites)

Duke Cancer Center

Durham, North Carolina, 27710

United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Alexandra Thomas, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-02

Study Completion Date2027-12

Study Record Updates

Study Start Date2022-09-02

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer
Triple Negative Breast Cancer
Cardiovascular Complications