[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657162":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":45,"overallOfficials":27,"centralContacts":55,"locations":61,"responsibleParty":80,"collaborators":27,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":27,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":27,"enrollmentInfo":93,"targetDuration":27,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"The rate of unplanned reoperation","Surgery performed to treat complications related to breast reconstruction.","3 years",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Implant-Based Breast Reconstruction Complications","Defined as adverse events following implant-based breast reconstruction, including reconstruction-related surgical complications and implant-specific complications.",{"measure":18,"description":19,"timeFrame":20},"Locoregional recurrence","Locoregional recurrence is defined as the first documented recurrence in the ipsilateral chest wall or regional nodes.","5 years",{"measure":22,"description":23,"timeFrame":20},"Distant metastasis","Distant metastasis is the first confirmed recurrence in any distant organ\u002Fsite beyond the ipsilateral chest wall and regional nodes.",{"measure":25,"description":26,"timeFrame":20},"Overall survival","Overall survival is the time from randomization to death from any cause.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35,40],{"label":36,"type":37,"description":27,"interventionNames":38},"Conventionally fractionated radiotherapy","ACTIVE_COMPARATOR",[39],"Radiation: ConvRT",{"label":41,"type":42,"description":27,"interventionNames":43},"Hypofractionated radiotherapy","EXPERIMENTAL",[44],"Radiation: HypoRT",[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":27},"RADIATION","ConvRT","50Gy\u002F25Fx, 2Gy\u002FFx, once daily",[36],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":27},"HypoRT","42.56Gy\u002F16Fx, 2.66Gy\u002FFx, once daily",[41],[56],{"name":57,"role":58,"phone":59,"phoneExt":27,"email":60},"Jinli Ma, MD, PhD","CONTACT","+86-21-64175590","ma-jinli@outlook.com",[62],{"facility":63,"status":64,"city":65,"state":27,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","200032","China","CN",{"type":70,"coordinates":71},"Point",[72,73],121.45806,31.22222,{"lat":73,"lon":72},[76],{"name":77,"role":58,"phone":78,"phoneExt":27,"email":79},"Xiaofang Wang","86-21-64175590","xiaofang0708@yeah.net",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Jinli Ma","Professor","100657162","hypofractionated-vs-conventionally-fractionated-postmastectomy-radiotherapy-after-implant-based-reconstruction-100657162",false,"NCT07835139","Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction","Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial","Inclusion Criteria:\n\n* Female patients aged ≥ 18 years.\n* Pathologically confirmed unilateral primary invasive breast cancer.\n* Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node biopsy or axillary lymph node dissection).\n* Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or subpectoral placement.\n* Received standard neoadjuvant or adjuvant systemic therapy (chemotherapy, endocrine, anti-HER2, or targeted therapy) according to guidelines or clinical trial protocols.\n* Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c\u002FpT1-3 N0-3 M0).\n* Interval of at least 6 weeks between reconstruction surgery and the initiation of radiotherapy.\n* ECOG performance status 0-1.\n* Prior non-breast malignancy permitted if disease-free for \\> 5 years with low recurrence risk; prior cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma permitted regardless of disease-free interval.\n* Estimated life expectancy ≥ 10 years.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Pregnant or lactating patients.\n* Prior history of breast cancer.\n* Bilateral breast cancer.\n* Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas.\n* T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to neoadjuvant systemic therapy).\n* Non-breast malignancy within the past 5 years (except cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma).\n* Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding radiotherapy tolerance or follow-up compliance.","FEMALE","18 Years",{"count":94,"type":95},534,"ESTIMATED","INTERVENTIONAL",[98],"NA","This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.",[101,102],"Breast Cancer","Implant Breast Reconstruction",[104,105,41],"Breast cancer","Implant-based breast reconstruction","2026-09-18",{"date":108,"type":109},"2026-09-22","ACTUAL",{"date":111,"type":95},"2026-10",{"date":113,"type":95},"2035-10",{"name":5,"class":6},1]