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NOT YET RECRUITING
NCT07723469
PHASE3

Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery

Sponsor: SURGE Therapeutics

View on ClinicalTrials.gov

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

Interventions

DRUG

BCS + SRG-514

BCS + SRG-514

PROCEDURE

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