Purpose of this Study
We are doing this study to better understand how breast cancer treatment can affect the heart. In particular, we want to know if treatment with near complete estrogen deprivation (NCED) therapy has an impact on heart function.
Who Can Participate?
Eligibility
Women ages 55 or younger who:<ul>
<li>Are premenopausal when they receive their breast cancer diagnosis</li>
<li>Have Stage 1-to-3 breast cancer</li>
<li>Have recently started or plan to start breast cancer treatment therapy</li></ul>
For more information about who can be in this study, please contact the study team at <a href="BreastCl@dm.duke.edu">BreastCl@dm.duke.edu.</a>
<li>Are premenopausal when they receive their breast cancer diagnosis</li>
<li>Have Stage 1-to-3 breast cancer</li>
<li>Have recently started or plan to start breast cancer treatment therapy</li></ul>
For more information about who can be in this study, please contact the study team at <a href="BreastCl@dm.duke.edu">BreastCl@dm.duke.edu.</a>
Age Range
18-55
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:<ul>
<li>Have 3 heart stress tests over the course of 2 years</li>
<li>Have a cardiac MRI at the beginning of the study, at the 1 year mark, and at the end of the study</li>
<li>Get a CT scan at the beginning of the study and 2 years later at the end</li>
<li>Have an EKG/ECG (measures the electrical signal from the heart) 3 times</li>
<li>Have up to 6 blood draws throughout the study</li></ul>
<li>Have 3 heart stress tests over the course of 2 years</li>
<li>Have a cardiac MRI at the beginning of the study, at the 1 year mark, and at the end of the study</li>
<li>Get a CT scan at the beginning of the study and 2 years later at the end</li>
<li>Have an EKG/ECG (measures the electrical signal from the heart) 3 times</li>
<li>Have up to 6 blood draws throughout the study</li></ul>
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
The Cardiac Outcomes with Near-complete Estrogen Deprivation (CROWN) Study
Principal Investigator
Alexandra
Thomas
Protocol Number
PRO00110774
NCT ID
NCT05309655
Phase
N/A
Enrollment Status
Open to Enrollment