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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05309655
Other study ID # IRB00083573
Secondary ID WFBCCC 98122P30C
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 2, 2022
Est. completion date December 2027

Study information

Verified date June 2024
Source Wake Forest University Health Sciences
Contact Study Coordinator
Phone 336-713-5435
Email jriley@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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Locations

Country Name City State
United States Duke Cancer Center Durham North Carolina
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Myocardial Blood Flow - 24 months 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. At baseline and at 24 months
Secondary Change in Myocardial Blood Flow - 12 months 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 At baseline and at 12 months
Secondary Change in Stiffness - Thoracic Pulse Wave Velocity Stiffness will be assessed by thoracic pulse wave velocity (PWV) and distensibility using 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 At 12 months and at 24 months
Secondary Change in Myocardial Perfusion Reserves Myocardial perfusion reserve will be measured with adenosine CMR imaging. Myocardial perfusion reserve is calculated as the percent change in myocardial blood flow between stress and rest perfusion 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 At 12 months and at 24 months
Secondary Number of Women at High Risk for Developing Deficits in Myocardial Blood Flow The predictive models developed to identify premenopausal women treated with an aromatase inhibitor for high-risk hormone receptor-positive breast cancer at highest risk for developing deficits in myocardial blood flow will incorporate variables related to demographics, medical history, and additional clinical variables. At 24 months
Secondary Overall Survival Disease outcomes will be monitored, including invasive-breast cancer free survival, at the annual visits throughout the study. With any change in anti-cancer therapy the specific reason for the change will be requested. Up to 5 years
Secondary Difference in Stress CMR Myocardial Blood Flow Total coronary plaque burden from coronary computed tomography angiography will be measured to assess the difference in heart function, including cardiac volumes and mass and blood flow in both groups. At baseline and at 24 months
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