[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578165":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":17,"overallOfficials":29,"centralContacts":37,"locations":43,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":17,"maxAge":87,"enrollmentInfo":88,"targetDuration":91,"studyType":92,"phases":17,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":46,"whyStopped":17,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Invasive Disease-Free Survival (iDFS) at 5 years","The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.","up to 30 months",[14],{"measure":15,"description":16,"timeFrame":12},"To describe the effect of the different adjuvant treatments according to clinical and genomic risk","Descriptive statistics, statistical measure of association, and logistic binomial regression modeling of the association measures between the iDFS at 5 years and explicative variables including adjuvant treatment received (chemo\u002Fendocrine therapy; endocrine therapy with or without OSF), pathological tumor status, and genomic risk score according to 21-multigene assay Oncotype DX.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":6,"maskingInfo":17},"COHORT","Premenopausal patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 with any Recurrence Score (RS) and pathological nodal status pN0\u002FpN1 will be included in the study. The study will collect clinical-pathological, genomic characteristics, adjuvant treatments (chemotherapy, endocrine therapy with\u002Fwithout OFS), and survival outcome (iDFS).","Patients with premenopausal early breast cancer HR+ HER2 negative diagnosis with any Recurrence Score (RS) and pathological nodal status pN0\u002FpN1 and who underwent the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.",[23,26],{"label":24,"type":17,"description":25,"interventionNames":17},"node negative (pN0)","Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test",{"label":27,"type":17,"description":28,"interventionNames":17},"node positive (pN1)","Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test",[30,34],{"name":31,"affiliation":32,"role":33},"Antonella Palazzo","Fondazione Policlinico Gemelli, IRCCS","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":36},"Alessandra Fabi","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":17,"email":42},"Clinical Research Technology","CONTACT","0039 089 301545","perseverex@cr-technology.com",[44,62],{"facility":45,"status":46,"city":47,"state":31,"zip":17,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Fondazione Policlinico Gemelli","RECRUITING","Roma","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],11.10642,44.99364,{"lat":54,"lon":53},[57,61],{"name":58,"role":40,"phone":59,"phoneExt":17,"email":60},"Antonella Palazzo MD","0039 0630155202","antonella.palazzo@policlinicogemelli.it",{"name":31,"role":40,"phone":17,"phoneExt":17,"email":17},{"facility":39,"status":63,"city":64,"state":17,"zip":17,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"NOT_YET_RECRUITING","Salerno",{"type":51,"coordinates":66},[67,68],14.79328,40.67545,{"lat":68,"lon":67},[71],{"name":39,"role":40,"phone":41,"phoneExt":17,"email":42},{"type":73,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[75],{"name":76,"class":77},"Clinical Research Technology S.r.l.","INDUSTRY","100578165","adjuvant-treatment-in-premenopausal-breast-cancer-100578165",false,"NCT06807749","Adjuvant Treatment in Premenopausal Breast Cancer","PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test","PERSEVEREX","Inclusion Criteria:\n\n1. Female, premenopausal and ≥18 years age patients.\n2. Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable\n3. Histological diagnosis of early breast cancer hormone positive (ER and\u002For PgR), HER2-negative.\n4. Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3.\n5. Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).\n6. Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022\n7. Availability of clinical and pathological information.\n8. Availability of information about adjuvant treatment received.\n9. Availability of patient' outcome information (relapse, site of relapse, survival).\n\nExclusion Criteria:\n\n1. Evidence of distant metastases\n2. Inflammatory breast cancer\n3. Neoadjuvant treatment\n4. No surgery for primary breast cancer and axillary staging\n5. Patients not tested with 21-multigene assay Oncotype DX","FEMALE","60 Years",{"count":89,"type":90},800,"ESTIMATED","24 Months","OBSERVATIONAL","Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.",[95],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[97,98],"Premenopausal early breast cancer","Oncotype Dx","2026-09-01",{"date":101,"type":102},"2026-09-03","ACTUAL",{"date":104,"type":102},"2025-12-24",{"date":106,"type":90},"2027-09",{"name":5,"class":6},2]