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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
SURGE Therapeutics
Study ID
NCT07723469
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCS + SRG-514 — DRUG
    BCS + SRG-514
  • BCS — PROCEDURE
    BCS

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2034
Completion
Oct 31, 2034

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: SRG-514 + BCS (breast conserving surgery)
    SRG-514 + BCS (breast conserving surgery)
  • Active Comparator: BCS
    BCS alone (breast conserving surgery)

Primary Outcome Measure

EFS by BICR assessment [ Time Frame: EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
MayoRochesterMinnesota55905
NYU Langone HealthNew YorkNew York10016
Duke Cancer CenterDurhamNorth Carolina27710
Melissa Rodgman
[email protected]

Find similar trials in Rochester, MN

By research site
Mayo· Rochester, MNNYU Langone Health· New York, NYDuke Cancer Center· Durham, NC

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