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

Starting soon · Phase 3

Conditions studied: TNBC - Triple-Negative Breast Cancer

In brief

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 facts

Study ID

NCT07723469

Run by

SURGE Therapeutics

People needed

400

Starts

2026-10-01

Expected to finish

2034-10-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Mayo — Rochester, Minnesota, United States
• NYU Langone Health — New York, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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