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Phase 3 SRG-514 for Triple-Negative Breast Cancer

This study is a Phase 3 trial for adults with stage II-III triple-negative breast cancer (TNBC) who have not yet received chemotherapy before surgery. It's testing if adding SRG-514 (ketorolac) directly into the surgical area during breast-conserving surgery (BCS) is better than standard care alone. Researchers want to see if SRG-514 can help prevent the cancer from returning or getting worse. The study aims to enroll 400 participants and will measure how long patients live without the cancer coming back or getting worse, for up to 5 years after surgery. You would need to have a confirmed diagnosis of TNBC.

Study design
This is a Phase 3, randomized, blinded study involving about 400 participants. Participants will be randomly assigned to receive either standard care plus SRG-514 during surgery, or standard care alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after breast-conserving surgery to track cancer recurrence or progression.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07723469

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

Not Yet Recruiting
PHASE3Ages 18+InterventionalPrevention
SURGE Therapeutics
~400 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:BCS + SRG-514BCS

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
EFS by BICR assessment
Measured over EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS.

Conditions

TNBC - Triple-Negative Breast Cancer

Explore related trials

Triple-Negative Breast Carcinoma

Where it's being run

3 sites across 3 states
Minnesota1
New York1
North Carolina1

Who to contact

Kayti Aviano
[email protected]
781-605-8632
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

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

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