[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"early-stage-invasive-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:early-stage-invasive-breast-carcinoma":29},{"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":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100651298","phase-3-partial-breast-irradiation-without-sentinel-lymph-node-biopsy-in-low-risk-early-breast-cancer-100651298",false,"NCT07757958","Partial Breast Irradiation Without Sentinel Lymph Node Biopsy in Low-Risk Early Breast Cancer","A Phase III Randomized Trial of Partial Versus Whole Breast Radiotherapy in Clinically Node-Negative Early Breast Cancer Omitting Sentinel Lymph Node Biopsy (APROOB Trial)","APROOB","Inclusion Criteria:\n\n* Female ≥40 years with histologically confirmed unilateral invasive breast cancer.\n* No suspicious nodal metastasis on preoperative axillary ultrasound (cN0).\n* Single lesion in the affected breast on preoperative breast ultrasound and mammography.\n* Treated with breast-conserving surgery with pathologically negative margins for the invasive tumor.\n* Sentinel lymph node biopsy not performed at surgery (pNx).\n* Maximum diameter of invasive tumor ≤2 cm on final pathology (pT1).\n* Histologic grade 1 or 2.\n* Signed informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* History of malignancy other than breast cancer within 5 years (except adequately treated non-melanoma skin cancer, or carcinoma in situ excluding breast carcinoma in situ).\n* Preoperative diagnosis of carcinoma in situ without axillary nodal sampling, subsequently diagnosed as invasive breast cancer on final pathology with SLNB omitted.\n* Lymphovascular invasion present (LVI+).\n* Multifocal or multicentric tumor in the same breast confirmed radiologically or pathologically.\n* Bilateral or inflammatory breast cancer.\n* Prior radiotherapy to the breast or thorax.\n* Confirmed pathogenic or likely pathogenic variant in a hereditary breast cancer gene (including BRCA1\u002F2).\n* Recurrent breast cancer.","FEMALE","40 Years",{"count":20,"type":21},520,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, phase III non-inferiority trial in women aged 40 years or older with clinically node-negative (cN0), pathologically pT1 (≤2 cm), grade 1-2, lymphovascular invasion (LVI)-negative invasive breast cancer treated with breast-conserving surgery (BCS) in whom sentinel lymph node biopsy (SLNB) was omitted (pNx). Eligible patients are randomized 1:1 to partial breast irradiation (PBI) or whole breast irradiation (WBI). The primary aim is to determine whether PBI is non-inferior to WBI with respect to the 5-year recurrence-free survival (RFS) rate. Secondary aims include comparison of axillary recurrence, overall survival, locoregional recurrence, treatment-related toxicity, and quality of life between arms.",[27,28,29],"Breast Cancer","Node-negative Breast Cancer","Early-Stage Invasive Breast Carcinoma",[31,32,33,34,35,36],"Partial breast irradiation","Whole breast irradiation","Breast-conserving surgery","Sentinel lymph node biopsy omission","Node-negative","Radiotherapy de-escalation","NOT_YET_RECRUITING","2026-08-06",{"date":40,"type":41},"2026-08-11","ACTUAL",{"date":43,"type":21},"2026-08-01",{"date":45,"type":21},"2036-06",{"name":47,"class":48},"Samsung Medical Center","OTHER"]