[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609700":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":59,"centralContacts":63,"locations":69,"responsibleParty":86,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":29,"enrollmentInfo":101,"targetDuration":29,"studyType":104,"phases":105,"briefSummary":108,"conditions":109,"keywords":29,"overallStatus":113,"whyStopped":29,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Ohio State University Comprehensive Cancer Center","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (eeCR, non-surgical)","EXPERIMENTAL","Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who achieve an ecCR will be placed in the non-surgical arm. Participants will receive radiation therapy and routine and additional screening MRIs during follow up.",[13,14,15,16,17],"Drug: Neoadjuvant Chemotherapy","Radiation: Radiation Therapy","Procedure: MRI","Procedure: Biopsy","Procedure: Biospecimen collection",{"label":19,"type":10,"description":20,"interventionNames":21},"Arm B (non-eeCR, surgical)","Patients will receive standard of care (SOC) neoadjuvant chemotherapy and will be evaluated for enhanced clinical complete response (ecCR) after treatment. Participants who do not achieve an ecCR will be placed in the surgical arm. Participants will undergo a lumpectomy or mastectomy, receive radiation therapy, and routine follow-up.",[13,14,15,22,16,17],"Procedure: Breast Cancer Surgery",[24,30,37,44,51,55],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Neoadjuvant Chemotherapy","Participants will receive standard of care neoadjuvant chemotherapy",[9,19],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"RADIATION","Radiation Therapy","Radiotherapy simulation parameters will be at the discretion of the treating physician to account for the patient's body habitus, tumor bed location, and tolerability of the prone or supine positions, however, the recommended approach will be whole-breast RT (WBRT) in the prone position, for cT1-3 N0 patients who achieve ecCR. For cT1-2 N1 patients who achieve ecCR WBRT with nodal inclusion and lymph node boost will be performed in the supine position.",[9,19],[36],"Radiotherapy",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"PROCEDURE","MRI","Participants will undergo MRI",[9,19],[43],"Magnetic Resonance Imaging",{"type":38,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Breast Cancer Surgery","Participants will undergo surgery to treat their breast cancer. Either a lumpectomy or a mastectomy will be performed.",[19],[49,50],"Lumpectomy","Mastectomy",{"type":38,"name":52,"description":53,"armGroupLabels":54,"otherNames":29},"Biopsy","Participants undergo biopsy",[9,19],{"type":38,"name":56,"description":57,"armGroupLabels":58,"otherNames":29},"Biospecimen collection","Participants undergo blood and plasma collection",[9,19],[60],{"name":61,"affiliation":5,"role":62},"Sachin Jhawar, MD","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":29,"email":68},"The Ohio State University Comprehensive Cancer Center","CONTACT","800-293-5066","OSUCCCClinicaltrials@osumc.edu",[70],{"facility":5,"status":29,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Columbus","Ohio","43210","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-82.99879,39.96118,{"lat":80,"lon":79},[83,85],{"name":61,"role":66,"phone":29,"phoneExt":29,"email":84},"Sachin.Jhawar@osumc.edu",{"name":61,"role":62,"phone":29,"phoneExt":29,"email":29},{"type":62,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Sachin Jhawar","Principal Investigator",[90],{"name":91,"class":6},"Gateway for Cancer Research","100609700","phase-1-neoadjuvant-complete-response-customized-treatment-approach-for-definitive-management-of-breast-cancer-100609700",false,"NCT07217990","Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer","NoCUT-BC","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype\n5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Inmate or prisoner\n3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment\n4. Patients with skin involvement and\u002For distant metastases","ALL","18 Years",{"count":102,"type":103},84,"ESTIMATED","INTERVENTIONAL",[106,107],"PHASE1","PHASE2","This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.",[110,111,112],"Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Cancer","NOT_YET_RECRUITING","2026-06-20",{"date":116,"type":117},"2026-06-24","ACTUAL",{"date":119,"type":103},"2026-09-15",{"date":121,"type":103},"2027-12-31",{"name":5,"class":6},1]