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NCT05309655 · ClinicalTrials.gov registry record · NA
Cardiac Outcomes With Near-Complete Estrogen Deprivation
A NA study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 3
- Study locations
NCT05309655: Recruiting NA study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Duke University.
NCT05309655 is a NA study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Duke University. The registered enrollment target is 90 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05309655, a NA study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Change in myocardial blood flow will be measured by adenosine CMR imaging. Comparisons will be made using longitudinal mixed models to examine within- and between- group effects on outcomes measured. These mixed models will include fixed effects for group (NCED/TNBC), baseline assessment of the outcome of interest (i.e. MPR) to adjust for potential risk-factor profile differences between groups and the time point at which the measurements are made relative to the baseline assessment.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Electrocardiogram
- DRUG Adenosine Stress Cardiac Magnetic Resonance Imaging
- DIAGNOSTIC_TEST Computed Tomography Angiogram
- OTHER Laboratory Testing
- BEHAVIORAL Quality of Life Survey
Study Locations (3)
North Carolina
- Duke Cancer Center - Durham
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Virginia
- Virginia Commonwealth University Massey Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2028-12-01 |
| Phase | NA |
What NCT05309655 shows while recruiting
NCT05309655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Electrocardiogram is the first listed.
NCT05309655 reports a single indexed study location in North Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT05309655 about?
NCT05309655 is a clinical study titled "Cardiac Outcomes With Near-Complete Estrogen Deprivation". 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.
What is the current status of trial NCT05309655?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2022-09-02. Estimated completion is 2028-12-01.
What conditions does trial NCT05309655 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, Cardiovascular Complications.
What interventions are being tested in trial NCT05309655?
The interventions under investigation include: Electrocardiogram (DIAGNOSTIC_TEST), Adenosine Stress Cardiac Magnetic Resonance Imaging (DRUG), Computed Tomography Angiogram (DIAGNOSTIC_TEST), Laboratory Testing (OTHER), Quality of Life Survey (BEHAVIORAL).
Who is sponsoring clinical trial NCT05309655?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05309655 being conducted?
This trial has 3 study locations across North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05309655's enrollment target sits among peer trials
90 613th of 1224 higher than 604 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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