[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570261":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":49,"collaborators":53,"id":56,"slug":25,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":25,"enrollmentInfo":65,"targetDuration":25,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No SLNB group","EXPERIMENTAL","The study arm - BCS without SLNB",[13],"Procedure: No axillary surgery",{"label":15,"type":6,"description":16,"interventionNames":17},"SLNB group","The control arm - BCS with SLNB(+\u002F-ALND)",[18],"Procedure: Axillary surgery",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","No axillary surgery","BCS only. Ommission of axillary surgery. No axillary surgery after neoadjuvant chemotherapy.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Axillary surgery","BCS with SLNB(+\u002F-ALND)",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Wonshik Han, MD, PhD.","CONTACT","82-2-3461-6060","hanw@snu.ac.kr",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":25,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Seoul National University Hopsital","RECRUITING","Seoul","03080","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Wonshik Han","Professor",[54],{"name":55,"class":6},"Asan Medical Center","100570261",false,"NCT06704945","No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy","No Axillary Surgical Treatment in Clinically Lymph Node Negative Patients on Ultrasonography After Neoadjuvant Chemotherapy: A Prospective, Phase III Clinical Trial","Neo-NAUTILUS","Inclusion Criteria:\n\n* Women aged ≥19 years.\n* Histologically confirmed invasive breast carcinoma treated with neoadjuvant chemotherapy.\n* Clinical staging prior to NAC: cT1-3, cN0, M0 (AJCC 8th Edition).\n* If pre-NAC staging is cT1-3, cN1, M0, must meet the following criteria:\n\n  1. HER2-positive or triple-negative breast cancer (TNBC).\n  2. At least 30% reduction in tumor size on MRI after NAC (comparing pre- and post-NAC MRI).\n* Negative axillary lymph node status on ultrasound after NAC.\n* Planned for breast-conserving surgery with completed neoadjuvant chemotherapy (at least half the planned regimen must be completed).\n* ECOG performance status of 0-2.\n* Signed written informed consent before enrollment.\n\nExclusion Criteria:\n\n* History of any cancer within the past 5 years.\n* Bilateral breast cancer.\n* Patients requiring mastectomy.\n* Tumor size \\>5 cm after NAC.\n* Male breast cancer.\n* Pregnant or breastfeeding women.\n* Inability to understand and complete questionnaires.","FEMALE","19 Years",{"count":66,"type":67},464,"ESTIMATED","INTERVENTIONAL",[70],"PHASE3","NEO-NAUTILUS is a prospective, multicenter, randomized phase III clinical trial to evaluate whether omitting axillary lymph node surgery (ALND or SLNB) in clinically lymph node-negative breast cancer patients after neoadjuvant chemotherapy is non-inferior to performing SLNB in terms of 5-year disease-free survival.",[73,74,75],"Breast Cancer","Neoadjuvant Therapy","Sentinel Lymph Node Biopsy",[77,78,79,80,81],"Omission of axillary surgery after neoadjuvant chemotherapy","Breast cancer","Neoadjuvant chemotherapy","De-escalation","Omission of surgery","2026-01-26",{"date":84,"type":85},"2026-01-28","ACTUAL",{"date":87,"type":85},"2025-06-04",{"date":89,"type":67},"2034-12-31",{"name":5,"class":6},1]