A Randomized, Phase 3 Trial of SRG-514 Administered Intraoperatively to the Site of Tumor Resection in Patients Undergoing Breast-Conserving Surgery for Triple Negative Breast Cancer
SURGE Therapeutics
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.
Description
This is a Phase 3, multicenter, randomized, blinded 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. Participants will be randomized 1:1 to receive SOC plus SRG-514 administered intraoperatively (treatment group) or SOC alone (control group). All participants will receive pre-operative and post-operative S…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugBCS + SRG-514
BCS + SRG-514
- ProcedureBCS
BCS
Locations (3)
- MayoRochester, Minnesota
- NYU Langone HealthNew York, New York
- Duke Cancer CenterDurham, North Carolina