[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598478":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":10,"locations":28,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tamoxifen±OFS external control arm",null,"data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen",[13],"Other: ribociclib",{"label":15,"type":10,"description":16,"interventionNames":17},"Ribociclib+NSAI+OFS arm","Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"OTHER","ribociclib","This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement.",[15,9],[25],{"name":26,"affiliation":26,"role":27},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[29],{"facility":30,"status":10,"city":31,"state":10,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":10},"Novartis investigative site","München","80333","Germany","DE",{"type":36,"coordinates":37},"Point",[38,39],13.31243,51.60698,{"lat":39,"lon":38},{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100598478","an-indirect-treatment-comparison-of-the-effectiveness-of-ribociclib-combined-with-non-steroidal-aromatase-inhibitors-vs-tamoxifen-for-the-adjuvant-treatment-of-premenopausal-women-with-hormon-receptor-positive-her2-negative-early-breast-cancer-100598478",false,"NCT07072013","An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer","An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer (IRINA)","IRINA","Inclusion Criteria:\n\n* Premenopausal women between 18 and 60 years\n* HR-positive, HER2-negative EBC without distant metastases\n* Patients must belong to one of the following categories according to the American Joint Committee on Cancer (AJCC):\n\n  * Anatomic Stage Group III,\n  * Anatomic Stage Group IIB,\n  * Anatomic Stage Group IIA that it either:\n\n    * N1,\n    * N0 with the following criteria:\n* Grade 3\n* Grade 2, with any of the following criteria:\n\n  * Ki67 ≥ 20 % or\n  * Oncotype DX Breast Recurrence Score ≥ 26 or\n  * Prosigna\u002FPAM50 categorized as high risk or\n  * MammaPrint categorized as high risk or\n  * EndoPredict EPclin Risk Score categorized as high risk.\n  * Patients with Cyclin-dependent Kinase 4\u002F6 (CDK4\u002F6) inhibitor treatment other than ribociclib+NSAI+OFS were excluded\n  * Patients in a bad general condition \\[Eastern Cooperative Oncology Group (ECOG) Status \\> 1\\] or with a limited life expectancy \\\u003C 5 years were excluded","FEMALE","18 Years","60 Years",{"count":55,"type":56},1937,"ACTUAL","OBSERVATIONAL","The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function Suppression (OFS) investigated in the global NATALEE trial (CLEE011O12301C, NCT 03701334) vs. tamoxifen±OFS using patients treated in German routine care as external control",[60],"Breast Cancer",[62,63,64,65,66],"Ribociclib,","early breast cancer,","indirect treatment comparison,","tamoxifen,","premenopausal","COMPLETED","2025-07-16",{"date":70,"type":56},"2025-07-18",{"date":72,"type":56},"2023-09-08",{"date":74,"type":56},"2025-04-24",{"name":26,"class":6},1]