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

NCT07723469 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: SRG-514-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Intraoperative; Ketorolac; SRG-514; Breast Cancer; TNBC; Lumpectomy; Breast Conserving Surgery; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• EFS by BICR assessment

  To compare the efficacy of SOC plus SRG-514 administered intraoperatively to the tumor resection site versus SOC alone in participants undergoing BCS

  EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS.

Secondary Outcomes (1)

• Incidence and severity of TEAEs

  Events will be followed for up to 5 years post BCS.

Study Arms (2)

SRG-514 + BCS (breast conserving surgery)

EXPERIMENTAL

SRG-514 + BCS (breast conserving surgery)

Drug: BCS + SRG-514

BCS

ACTIVE COMPARATOR

BCS alone (breast conserving surgery)

Procedure: BCS

Interventions

BCS + SRG-514 DRUG

BCS + SRG-514

SRG-514 + BCS (breast conserving surgery)

BCS PROCEDURE

BCS

BCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants will be adults (≥18 years old) who have a history of histologically confirmed diagnosis of TNBC (clinical stage II-III), except inflammatory breast cancer. Bilateral and/or multifocal primary tumors are allowed. For multifocal/multicentric disease, diagnosis needs to be confirmed for each focus. Participants have confirmed TNBC (as defined by the 8th edition of American Joint Committee on Cancer \[AJCC\] cancer staging manual and National Comprehensive Cancer Network \[NCCN\] guidelines), Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤2, and plan to undergo breast-conserving surgical treatment of breast cancer with curative intent within 28 days of Screening.

You may not qualify if:

• Participants will not be eligible if they anticipate requiring the use of a drain after BCS, and/or have received neoadjuvant therapy, and/or are undergoing immediate reconstruction surgery with flaps involving transposition of a vascularized tissue flap from a remote donor site (oncoplastic closures are allowed), intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure, and/or have a history of invasive malignancy (other than the disease under trial, ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer), and/or have stage IV disease.

Sponsors & Collaborators

• SURGE Therapeutics: lead

Study Sites (3)

Mayo

Rochester, Minnesota, 55905, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Kayti Aviano

CONTACT

781-605-8632; kayti@surgetx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive 514 + BCS or BCS alone.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2034
• Study Completion (Estimated): October 1, 2034
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (3)