[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wonshik Han\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":20,"type":21},1520,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Breast Cancer (Early Breast Cancer)","Sentinel Lymph Node Biopsy","NOT_YET_RECRUITING","2026-10-04",{"date":32,"type":33},"2026-10-08","ACTUAL",{"date":35,"type":21},"2026-10-01",{"date":37,"type":21},"2034-10-01",{"name":39,"class":40},"Wonshik Han","OTHER",""]