[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651298":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Whole Breast Irradiation (WBI)","ACTIVE_COMPARATOR","Whole breast irradiation using 3D conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT).",[13],"Radiation: Whole Breast Irradiation",{"label":15,"type":16,"description":17,"interventionNames":18},"Partial Breast Irradiation (PBI)","EXPERIMENTAL","Partial breast irradiation targeting the tumor bed with margin, using 3D-CRT or IMRT, sparing the remainder of the breast.",[19],"Radiation: Partial Breast Irradiation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Whole Breast Irradiation","Total dose 26-45 Gy in 5-20 fractions; each institution applies a pre-selected fractionation schedule consistently.\n\nCTV defined per ESTRO guideline to include the whole breast parenchyma; PTV with institutional set-up margin (e.g., 5-7 mm).\n\nTumor bed boost (sequential 10-16 Gy in 4-8 fractions, or simultaneous integrated boost \\[SIB\\]) per institutional standard.\n\nRegional nodal irradiation and high-tangent technique not permitted; axillary levels I-III contoured for dosimetric analysis only.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Partial Breast Irradiation","Total dose 30-40 Gy in 5-15 fractions. Recommended schedules: 30 Gy in 5 fractions (once daily \\[QD\\] or twice daily \\[BID\\]); or 40.05 Gy in 15 fractions (QD over \\~3 weeks).\n\nAxillary levels I-III contoured for incidental dosimetric analysis only (not a treatment target).",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Haeyoung Kim","CONTACT","+82234102612","haeyoung0131.kim@samsung.com",[38],{"facility":5,"status":26,"city":39,"state":26,"zip":40,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Seoul","05649","South Korea",{"type":43,"coordinates":44},"Point",[45,46],126.9784,37.566,{"lat":46,"lon":45},[49,50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":51,"role":34,"phone":26,"phoneExt":26,"email":52},"Wonkyung Cho","wklove.cho@gmail.com",{"type":54,"investigatorFullName":33,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Professor",[57],{"name":58,"class":59},"National Institute of Health, Korea","OTHER_GOV","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":71,"type":72},520,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78,79,80],"Breast Cancer","Node-negative Breast Cancer","Early-Stage Invasive Breast Carcinoma",[82,83,84,85,86,87],"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":91,"type":92},"2026-08-11","ACTUAL",{"date":94,"type":72},"2026-08-01",{"date":96,"type":72},"2036-06",{"name":5,"class":6},1]