[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402208":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":57,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group","EXPERIMENTAL","whole breast\u002Fchest wall irradiation + SVC irradiation",[13],"Radiation: omit of IMI group",{"label":15,"type":16,"description":17,"interventionNames":18},"controlled group","ACTIVE_COMPARATOR","whole breast\u002Fchest wall irradiation + IMI+SVC irradiation",[19],"Radiation: IMI group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","omit of IMI group","clincial high risk breast （≥2 risk factors）patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"IMI group",[15],[31],{"name":32,"affiliation":5,"role":33},"Wei-Xiang Qi, Dr.","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+862164370045","qiweixiang1113@163.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ruijin Hospital, Shanghai jiaotong univestigy school of medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":37,"phoneExt":26,"email":26},"Yifeng Wang",{"type":33,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"QIWEIXIANG","Clinical Professor","100402208","evaluating-omitting-of-internal-mammary-irradiation-among-early-stage-intermediate-risk-n1-breast-cancer-100402208",false,"NCT04517266","Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer","Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer Patients According to Clinical-genomic Model: an Open Label, Non-inferior Randomized Controlled Trial","Inclusion Criteria:\n\n* • Histologically confirmed invasive breast cancer\n\n  * Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND)\n  * The number of positive lymph node should be 1-3 (N1).\n  * Clinical high risk breast cancer (≥2 clinical risk factors)\n  * Aged 18-80 years old\n  * ECOG performance status ≤2 (Karnofsky ≥70%) Anticipative overall survival \\>5 years Pathologically surgical margin \\>2mm ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation Ability to understand and willingness to participate the research and sign the consent form\n\nExclusion Criteria:\n\n* • Axillary dissection of less than 10 lymph nodes\n\n  * Pathologically positive ipsilateral supraclavicular lymph node\n  * Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes\n  * Pregnant or lactating women\n  * Treated with breast reconstruction surgery\n  * Severe non-neoplastic medical comorbidities\n  * History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix\n  * simultaneous contralateral breast cancer\n  * Previous radiotherapy to the neck, chest and\u002For ipsilateral axillary region\n  * Active collagen vascular disease\n  * Definitive pathological or radiologic evidence of distant metastatic disease\n  * Primary T4 tumor\n  * Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks","FEMALE","18 Years","80 Years",{"count":71,"type":72},214,"ESTIMATED","INTERVENTIONAL",[75],"NA","The effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.",[78],"Breast Cancer",[80,81,82,83,84,85,86],"breast cancer","N1","clinical-genomic model","genomic model","radiotherapy","internal mammary irradiation","clinical model","2026-08-10",{"date":89,"type":90},"2026-08-11","ACTUAL",{"date":92,"type":90},"2021-03-01",{"date":94,"type":72},"2030-10-30",{"name":5,"class":6},1]