MedTrace Logo

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

NCT07723469 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • TNBC - Triple-Negative Breast Cancer

Interventions

DRUG

BCS + SRG-514

BCS + SRG-514

PROCEDURE

BCS

BCS

Sponsors & Collaborators

  • SURGE Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2034-10-31
Completion
2034-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723469 on ClinicalTrials.gov