[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648416":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":79,"collaborators":24,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":24,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":24,"enrollmentInfo":90,"targetDuration":24,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":108,"whyStopped":24,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"SURGE Therapeutics","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"SRG-514 + BCS (breast conserving surgery)","EXPERIMENTAL",[12],"Drug: BCS + SRG-514",{"label":14,"type":15,"description":16,"interventionNames":17},"BCS","ACTIVE_COMPARATOR","BCS alone (breast conserving surgery)",[18],"Procedure: BCS",[20,25],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","BCS + SRG-514",[9],null,{"type":26,"name":14,"description":14,"armGroupLabels":27,"otherNames":24},"PROCEDURE",[14],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Kayti Aviano","CONTACT","781-605-8632","kayti@surgetx.com",[35,52,65],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Mayo","Rochester","Minnesota","55905","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-92.4699,44.02163,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":24,"phoneExt":24,"email":51},"Kara Brandt","Brandt.Kara@mayo.edu",{"facility":53,"status":24,"city":54,"state":54,"zip":55,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"NYU Langone Health","New York","10016",{"type":43,"coordinates":57},[58,59],-74.00597,40.71427,{"lat":59,"lon":58},[62],{"name":63,"role":31,"phone":24,"phoneExt":24,"email":64},"Pam Rajan","ManjuPamela.Rajan@nyulangone.org",{"facility":66,"status":24,"city":67,"state":68,"zip":69,"country":40,"countryCode":41,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Duke Cancer Center","Durham","North Carolina","27710",{"type":43,"coordinates":71},[72,73],-78.89862,35.99403,{"lat":73,"lon":72},[76],{"name":77,"role":31,"phone":24,"phoneExt":24,"email":78},"Melissa Rodgman","melissa.rodgman@duke.edu",{"type":80,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100648416","phase-3-phase-3-trial-of-srg-514-administered-intraoperatively-to-patients-undergoing-breast-conserving-surgery-100648416",false,"NCT07723469","Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery","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","Inclusion Criteria:\n\n* 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\u002For multifocal primary tumors are allowed. For multifocal\u002Fmulticentric 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.\n\nExclusion Criteria:\n\n* Participants will not be eligible if they anticipate requiring the use of a drain after BCS, and\u002For have received neoadjuvant therapy, and\u002For 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\u002For 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\u002For have stage IV disease.","ALL","18 Years",{"count":91,"type":92},400,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","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.",[98],"TNBC - Triple-Negative Breast Cancer",[100,101,102,103,104,105,106,107],"Intraoperative","Ketorolac","SRG-514","Breast Cancer","TNBC","Lumpectomy","Breast Conserving Surgery","Immunotherapy","NOT_YET_RECRUITING","2026-07-20",{"date":111,"type":112},"2026-07-23","ACTUAL",{"date":114,"type":92},"2026-10",{"date":116,"type":92},"2034-10",{"name":5,"class":6},3]