[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622153":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":12,"locations":19,"responsibleParty":34,"collaborators":7,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":7,"enrollmentInfo":46,"targetDuration":49,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":58,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Endopredict test","Endopredict test was perfomed between 2016 and 2021 in expert french laboratories, for patient with early HR+\u002FHER2-breast cancer presenting insufficient clinical criteria to determine the need for adjuvant chemotherapy, in combination with hormone therapy, after breast surgery.\n\nEndopredict is a multigene signature that evaluates, on surgery tumor specimen, the expression of 11 genes (8 genes related to proliferation, apoptosis and HR signal transduction pathways and 3 control genes) by qRT-PCR to define a molecular EP score. The Ep score combined with two prognostic factors (tumour size pT and lymph node involvement pN) define the Epclin score. The Epclin score allows calculation of the risk of relapse at 10 years, the absolute benefit from chemoptherapy and the risk of late recurrence.",[13],{"name":14,"role":15,"phone":16,"phoneExt":17,"email":18},"Jacqueline LEHMANN-CHE, MD","CONTACT","01 56 09 21 11","+33","jacqueline.lehmann-che@aphp.fr",[20],{"facility":21,"status":22,"city":23,"state":7,"zip":7,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Hôpital Saint-Louis","RECRUITING","Paris","France","FR",{"type":27,"coordinates":28},"Point",[29,30],2.3488,48.85341,{"lat":30,"lon":29},[33],{"name":14,"role":15,"phone":16,"phoneExt":17,"email":18},{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100622153","real-life-evaluation-of-endopredict-in-early-hrher2--breast-cancer-100622153",false,"NCT07379918","Real-life Evaluation of Endopredict® in Early HR+\u002FHER2- Breast Cancer","French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer","SiMoSein","Inclusion Criteria:\n\n* Patient with early breast cancer, hormone receptor-positive, HER2 non-amplified, for whom clinical criteria are deemed insufficient to determine the need for adjuvant chemotherapy, combined with hormone therapy, after breast surgery.\n\nExclusion Criteria:\n\n* Patients who did not undergo testing or whose test results were not validated","FEMALE","18 Years",{"count":47,"type":48},1000,"ESTIMATED","10 Years","OBSERVATIONAL","EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+\u002FHER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide the adjuvant treatment decision: hormone therapy alone or hormone therapy and chemotherapy.\n\nSince 2016, french laboratories performing the Endopredict test, included prospectively analyzed tumors in the SiMoSein registry with data collection : age, tumor size, lymph node status, histology, grade, HR and HER2 IHC status, Ki67, EPscore, Epclin score, risk of relapse, absolue benefit from chemotherapy, risk of late relapse\n\nThe main objectives of the trial are to:\n\nEvaluate long-term relapse-free survival and overall survival over a 10-year period in breast cancer patients who underwent EndoPredict® testing according to:\n\n* EPclin risk class (low vs. high),\n* Lymph node status (N0\u002FN1),\n* Tumor size (pT),\n* Age groups (\\\u003C40 years, 40-49 years, 50-69 years, ≥70 years),\n* EP score alone.\n\nThis study provide real-life data to determine the clinical usefulness of this molecular signature in the management of early HR+\u002FHER2- breast cancers. The ultimate goal is to be able to offer therapeutic de-escalation (avoiding chemotherapy) to patients who are reliably assessed as having a low risk of relapse.",[53,54,55,56,57],"Breast Cancer (Early Breast Cancer)","Breast Cancer Survivors","Breast Cancer Prognostic","Early Hormone Receptor-positive (HR-positive)","HER2-negative Breast Cancer",[59,60,61,62,63,64],"breast cancer","early breast cancer","EndoPredict test","survival","HR positive","HER2 negative","2026-03-12",{"date":67,"type":68},"2026-03-13","ACTUAL",{"date":70,"type":48},"2026-06-28",{"date":72,"type":48},"2031-06-28",{"name":5,"class":6},1]