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Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery
Sponsor: SURGE Therapeutics
Summary
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient \[API\]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical stage II-III triple negative breast cancer (TNBC) undergoing breast-conserving surgery (BCS) who are neoadjuvant therapy naïve.
Official title: A Randomized, Phase 3 Trial of SRG-514 Administered Intraoperatively to the Site of Tumor Resection in Patients Undergoing Breast-Conserving Surgery for Triple Negative Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-10
Completion Date
2034-10
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
BCS + SRG-514
BCS + SRG-514
BCS
BCS
Locations (3)
Mayo
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States