[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657712":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":36,"interventions":49,"overallOfficials":28,"centralContacts":58,"locations":64,"responsibleParty":77,"collaborators":28,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":28,"enrollmentInfo":91,"targetDuration":28,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":28,"overallStatus":101,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Invasive disease free survival","Invasive disease-free survival is defined as the time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence, local or regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause, according to the STEEP criteria.","5 years after randomization",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Overall survival","Description: Overall survival is defined as the time from randomization to death from any cause.","5 years from randomization",{"measure":19,"description":20,"timeFrame":17},"Distant disease-free survival","Distant disease-free survival is defined as the time from randomization to the first occurrence of distant recurrence or death from any cause, according to the STEEP criteria.",{"measure":22,"description":23,"timeFrame":17},"Axillary recurrence","Axillary recurrence is defined as histologically or cytologically confirmed recurrence in the ipsilateral axillary lymph nodes, occurring as a first event or concurrently with other recurrence sites.",{"measure":25,"description":26,"timeFrame":27},"Health-related quality of life","Health-related quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires. Scores are linearly transformed to a 0-100 scale. Higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate greater symptom burden.","Before surgery, and 1 and 2 years after surgery",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"RANDOMIZED","PARALLEL","A multicenter, randomized, parallel-group, non-inferiority trial comparing omission of axillary surgery with standard axillary surgery in patients with low-risk clinically node-negative breast cancer.","TREATMENT",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"SLN omission group","EXPERIMENTAL","No axillary surgery",[42],"Procedure: Omission of axillary surgery",{"label":44,"type":45,"description":46,"interventionNames":47},"SLN group","ACTIVE_COMPARATOR","Sentinel lymph node biopsy",[48],"Procedure: Sentinel lymph node biopsy",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":28},"PROCEDURE","Omission of axillary surgery","Planned breast surgery is performed without any axillary surgical procedure. Neither sentinel lymph node biopsy nor axillary lymph node dissection is performed. Adjuvant treatment decisions are made without pathologic nodal information",[38],{"type":51,"name":46,"description":56,"armGroupLabels":57,"otherNames":28},"Sentinel lymph node biopsy is performed at the time of planned breast surgery. Subsequent axillary management and adjuvant treatment decisions follow institutional standard practice based on the pathologic nodal findings.",[44],[59],{"name":60,"role":61,"phone":62,"phoneExt":28,"email":63},"Wonshik Han, Professor","CONTACT","82-2-2072-0706","hanw@snu.ac.kr",[65],{"facility":5,"status":28,"city":66,"state":28,"zip":67,"country":68,"countryCode":28,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Seoul","03080","South Korea",{"type":70,"coordinates":71},"Point",[72,73],126.9784,37.566,{"lat":73,"lon":72},[76],{"name":60,"role":61,"phone":62,"phoneExt":28,"email":63},{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Wonshik Han","Professor, Department of surgery","100657712","nautilus-04-no-axillary-surgical-treatment-in-low-risk-clinically-node-negative-breast-cancer-without-whole-breast-radiotherapy---a-prospective-randomized-phase-iii-non-inferiority-clinical-trial-100657712",false,"NCT07841704","NAUTILUS-04: No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy","A Multicenter Randomized Controlled Non-Inferiority Trial of No Axillary Surgical Treatment in Low-Risk Clinically Node-Negative Breast Cancer Without Whole-Breast Radiotherapy","NAUTILUS-04","Inclusion Criteria:\n\n* Postmenopausal women aged 55 years or older\n* Histologically confirmed invasive breast cancer\n* Estrogen receptor-positive and HER2-negative\n* Clinical T1-2\n* Clinically node-negative by physical examination and axillary ultrasound\n* No neoadjuvant systemic therapy\n* Not planned to receive whole-breast radiotherapy\n* Planned for one of the following local treatments:\n* Cohort 1: Breast-conserving surgery without radiotherapy\n* Age under 65 years with clinical T1 tumor and biologically low risk, defined as Oncotype DX Recurrence Score 18 or less, OncoFREE Decision Index 15 or less, or Ki-67 13.25% or less with histologic grade 1 or 2\n* Age 65 years or older with clinical tumor size 3 cm or less and histologic grade 1 or 2\n* Cohort 2: Breast-conserving surgery with accelerated partial breast irradiation, with clinical T1 tumor and histologic grade 1 or 2\n* Cohort 3: Mastectomy without radiotherapy, with histologic grade 1 or 2\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinically or radiologically suspicious axillary lymph nodes\n* Prior ipsilateral invasive breast cancer or prior axillary surgery\n* Bilateral breast cancer\n* Inflammatory breast cancer\n* Pregnancy\n* Any condition that precludes protocol-specified surgery or follow-up\n* Concurrent participation in another interventional clinical trial that may affect the primary endpoint of this study","FEMALE","55 Years",{"count":92,"type":93},1520,"ESTIMATED","INTERVENTIONAL",[96],"NA","The safety of omitting sentinel lymph node biopsy (SLNB) has been established only in patients undergoing breast-conserving surgery with whole-breast radiotherapy, as demonstrated in the prior randomized trials. Whether SLNB can be omitted in patients who will not receive whole-breast radiotherapy remains unknown, despite the parallel expansion of radiotherapy de-escalation in low-risk populations.\n\nNAUTILUS-04 is a prospective, multicenter, randomized, phase III non-inferiority trial evaluating the oncologic safety of SLNB omission in postmenopausal patients with low-risk, clinically node-negative breast cancer who are not planned to receive whole-breast radiotherapy.\n\nEligible patients are postmenopausal women aged 55 years or older with estrogen receptor-positive, HER2-negative invasive breast cancer, clinical T1-2 and clinically node-negative disease confirmed by physical examination and axillary ultrasound, without neoadjuvant systemic therapy. Patients must be planned for one of three local treatments: breast-conserving surgery without radiotherapy, breast-conserving surgery with accelerated partial breast irradiation, or mastectomy without radiotherapy.\n\nA total of 1,520 patients will be randomized 1:1 to SLNB or no axillary surgery, stratified by planned breast surgery (breast-conserving surgery versus mastectomy) and age (55-64 versus 65 years or older). The primary endpoint is 5-year invasive disease-free survival. Secondary endpoints include 5-year axillary recurrence-free survival, distant recurrence-free survival, overall survival, and quality of life assessed by the EORTC QLQ questionnaire.",[99,100],"Breast Cancer (Early Breast Cancer)","Sentinel Lymph Node Biopsy","NOT_YET_RECRUITING","2026-10-04",{"date":104,"type":105},"2026-10-08","ACTUAL",{"date":107,"type":93},"2026-10-01",{"date":109,"type":93},"2034-10-01",{"name":79,"class":6},1]