[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656919":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":28,"interventions":41,"overallOfficials":21,"centralContacts":51,"locations":57,"responsibleParty":75,"collaborators":21,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":21,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":21,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":60,"whyStopped":21,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse cosmesis","Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.","3 years",[14,18],{"measure":15,"description":16,"timeFrame":17},"Rate of locoregional recurrence","Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.","5 years",{"measure":19,"description":20,"timeFrame":17},"Overall survival","Overall survival is the time from randomization to death from any cause.",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"arm 1","EXPERIMENTAL","26Gy\u002F5F",[34],"Radiation: 1-week PBI",{"label":36,"type":37,"description":38,"interventionNames":39},"arm 2","ACTIVE_COMPARATOR","40.05Gy\u002F15F",[40],"Radiation: 3-week PBI",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":21},"RADIATION","3-week PBI","40.05Gy\u002F15Fx\u002F3w, 2.67Gy\u002FFx, once daily",[36],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":21},"1-week PBI","26Gy\u002F5Fx\u002F1w, 5.2Gy\u002FFx, once daily",[30],[52],{"name":53,"role":54,"phone":55,"phoneExt":21,"email":56},"Jinli Ma","CONTACT","+86-21-64175590","ma-jinli@outlook.com",[58],{"facility":59,"status":60,"city":61,"state":21,"zip":21,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":65,"coordinates":66},"Point",[67,68],121.45806,31.22222,{"lat":68,"lon":67},[71],{"name":72,"role":54,"phone":73,"phoneExt":21,"email":74},"Xiaofang Wang","(86)-21-64175590","xiaofang0708@yeah.net",{"type":76,"investigatorFullName":53,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Professor","100656919","1-week-versus-3-week-pbi-100656919",false,"NCT07832279","1-Week Versus 3-Week PBI","1-Week Versus 3-Week Partial Breast Irradiation Using Intensity-Modulated Radiation Therapy (IMRT) Following Breast-Conserving Surgery in Clinically Low-Risk Breast Cancer: a Phase III, Randomized Trial","Inclusion Criteria:\n\n* Female patients with an estimated life expectancy greater than 5 years. Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS).\n* For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric\u002Funifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and\u002For PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm.\n* For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm.\n* Presence of surgical clips or distinct postoperative seroma\u002Ftissue changes in the tumor bed allowing precise target delineation.\n* ECOG performance status 0 or 1.\n* Eligible for systemic therapy, without prior neoadjuvant systemic therapy.\n* Able to tolerate radiotherapy procedures and position immobilization.\n* No contraindications to radiotherapy.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma).\n* Positive axillary, internal mammary, or supraclavicular lymph nodes.\n* Presence of distant metastasis.\n* Paget's disease of the nipple.\n* History of prior ipsilateral or contralateral invasive breast cancer or DCIS.\n* Bilateral breast cancer.\n* Known germline BRCA1 or BRCA2 mutation.\n* Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes.\n* Active or prior second malignancy (except adequately treated non-melanoma skin cancer).\n* Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy.\n* Pregnant or lactating patients.\n* Inability or unwillingness to comply with scheduled follow-up visits.","FEMALE","18 Years","75 Years",{"count":89,"type":90},818,"ESTIMATED","INTERVENTIONAL",[93],"NA","This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy\u002F5 Fx) versus a three-week regimen (40 Gy\u002F15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery.",[96],"Early-Stage Breast Cancer",[98,99,48,44],"Partial breast irradiation","Early-stage breast cancer","2026-09-22",{"date":102,"type":103},"2026-09-25","ACTUAL",{"date":105,"type":90},"2026-10",{"date":107,"type":90},"2034-10",{"name":5,"class":6},1]