Administering SRG-514 during breast-conserving cancer surgery
Official title: A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery
Run by SURGE Therapeutics · NCT06300411 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new drug called SRG-514 during breast-conserving surgery to see how much can be safely given to patients with breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | SURGE Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Savannah, Georgia and 5 other locations) |
| Trial ID | NCT06300411 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a confirmed diagnosis of breast carcinoma planning to undergo breast-conserving surgery.
✕Probably not a fit
Patients with contraindications to ketorolac or those requiring immediate reconstruction surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, first-in-human trial aims to determine the recommended Phase 2 dose (RP2D) of SRG-514 when given to patients undergoing breast-conserving surgery for breast cancer. The study employs a dose escalation methodology, enrolling 3 to 6 patients at each dose level, with a total of approximately 12-18 patients in the initial phase. The primary focus is on assessing safety and identifying any dose-limiting toxicities within 14 days following administration. Patients with a confirmed diagnosis of breast carcinoma will be included, provided they meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this treatment could improve pain management and recovery outcomes for patients undergoing breast-conserving surgery.
How similar studies have gone: Other studies have explored similar intraoperative interventions, but this specific approach with SRG-514 is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Body weight \>50kg * Have a history of histologically confirmed diagnosis of breast carcinoma or ductal carcinoma in situ, except inflammatory breast cancer. * Plan to undergo breast-conserving surgical treatment of breast cancer with curative intent. Adjuvant or neoadjuvant chemotherapy is allowed. * Have Eastern Cooperative Oncology Group (ECOG) Performance Status \<2 * Have adequate organ and bone marrow function at screening Exclusion Criteria: * Any known contraindication to ketorolac or other non-steroidal anti-inflammatory drugs (NSAIDs) * Patients anticipated to require the use of a drain after breast-conserving surgery (BCS) * Patients undergoing immediate reconstruction surgery, intraoperative radiation therapy (IORT) or brachytherapy requiring the placement of balloons or catheters during the lumpectomy procedure.
Where it's running
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Memorial Health
Savannah, Georgia, United States Recruiting -
Indiana University
Indianapolis, Indiana, United States Recruiting -
Washington University School of Medicine
Saint Louis, Missouri, United States Recruiting -
NYU Langone Health
New York, New York, United States Recruiting -
Duke Cancer Center
Durham, North Carolina, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Kayti Aviano
- Email: kayti@surgetx.com
- Phone: 781-605-8632
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.