[{"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":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"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","phase-3-no-axillary-surgical-treatment-in-clinically-lymph-node-negative-patients-on-ultrasonography-after-neoadjuvant-chemotherapy-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":67,"type":68},464,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75,76],"Breast Cancer","Neoadjuvant Therapy","Sentinel Lymph Node Biopsy",[78,79,80,81,82],"Omission of axillary surgery after neoadjuvant chemotherapy","Breast cancer","Neoadjuvant chemotherapy","De-escalation","Omission of surgery","2026-01-26",{"date":85,"type":86},"2026-01-28","ACTUAL",{"date":88,"type":86},"2025-06-04",{"date":90,"type":68},"2034-12-31",{"name":5,"class":6},1]