[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723469":3,"trial-entities:NCT07723469":114,"trial-summary:NCT07723469":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":46,"secondary_outcomes":51,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":65,"locations":68,"central_contacts":106,"overall_officials":111,"references":112,"see_also_links":113},"NCT07723469","SRG-514-02","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","NOT_YET_RECRUITING","2034-10","2026-07","2026-07-23","2026-10","SURGE Therapeutics","INDUSTRY",false,"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.","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 SOC.",[19],"TNBC - Triple-Negative Breast Cancer",[21,22,23,24,25,26,27,28],"Intraoperative","Ketorolac","SRG-514","Breast Cancer","TNBC","Lumpectomy","Breast Conserving Surgery","Immunotherapy","INTERVENTIONAL","PREVENTION",[32],"PHASE3",{"count":34,"type":35},400,"ESTIMATED",[37,42],{"type":38,"name":39,"description":39,"armGroupLabels":40},"DRUG","BCS + SRG-514",[41],"SRG-514 + BCS (breast conserving surgery)",{"type":43,"name":44,"description":44,"armGroupLabels":45},"PROCEDURE","BCS",[44],[47],{"measure":48,"description":49,"timeFrame":50},"EFS by BICR assessment","To compare the efficacy of SOC plus SRG-514 administered intraoperatively to the tumor resection site versus SOC alone in participants undergoing BCS","EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS.",[52],{"measure":53,"description":54,"timeFrame":55},"Incidence and severity of TEAEs","To determine the safety and tolerability of SRG-514 administered intraoperatively to the tumor resection site in participants undergoing BCS","Events will be followed for up to 5 years post BCS.","ALL","18 Years",null,{"inclusion":60,"exclusion":62,"raw_text":64},[61],"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.",[63],"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.","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.",[66,67],"ADULT","OLDER_ADULT",[69,83,94],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":80},"Mayo","Rochester","Minnesota","55905","United States",[76],{"name":77,"role":78,"email":79},"Kara Brandt","CONTACT","Brandt.Kara@mayo.edu",{"lat":81,"lon":82},44.02163,-92.4699,{"facility":84,"city":85,"state":85,"zip":86,"country":74,"contacts":87,"geoPoint":91},"NYU Langone Health","New York","10016",[88],{"name":89,"role":78,"email":90},"Pam Rajan","ManjuPamela.Rajan@nyulangone.org",{"lat":92,"lon":93},40.71427,-74.00597,{"facility":95,"city":96,"state":97,"zip":98,"country":74,"contacts":99,"geoPoint":103},"Duke Cancer Center","Durham","North Carolina","27710",[100],{"name":101,"role":78,"email":102},"Melissa Rodgman","melissa.rodgman@duke.edu",{"lat":104,"lon":105},35.99403,-78.89862,[107],{"name":108,"role":78,"phone":109,"email":110},"Kayti Aviano","781-605-8632","kayti@surgetx.com",[],[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Triple-Negative Breast Carcinoma",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"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.","completed","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.","Participants will be followed for up to 5 years after breast-conserving surgery to track cancer recurrence or progression.",100,"Not specified in the trial record.","Not stated in the trial record.",[44],"v2"]