Purpose of this Study
We are doing this study to find out if an experimental drug called SRG-514 (the study drug) is a safe and effective option for breast cancer patients. We want to know if it can reduce the inflammation caused by surgery and allow your body to better heal itself and prevent tumor recurrence. We will also be trying to figure out the best dose of the drug to use.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with breast carcinoma or ductal carcinoma in situ
- Plan to have breast-conserving surgical treatment
- Do not have a diagnosis of inflammatory breast cancer
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, the study drug will be placed directly into your breast in the area where your tumor is removed. You will need to return to Duke on days 1, 2, 7, 14, and 60 after your surgery for check-up visits with the study team.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients undergoing Breast-Conserving Cancer Surgery
Principal Investigator
Jennifer
Plichta
Protocol Number
PRO00115620
NCT ID
NCT06300411
Phase
I
Enrollment Status
Open to Enrollment