[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636277":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":39,"locations":45,"responsibleParty":92,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":10,"enrollmentInfo":108,"targetDuration":10,"studyType":111,"phases":10,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"iOMEDICO AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ESR1 wildtype",null,"Patients with a ESR1 wildtype tumor",[13],"Drug: Standard of care (Investigator Choice)",{"label":15,"type":10,"description":16,"interventionNames":17},"ESR1 mutated","Patients with a ESR1 mutated tumor",[18],"Drug: Elacestrant",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Elacestrant","According to the Summary of Product Characteristics (SmPC)",[15],[26],"Orserdu®",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Standard of care (Investigator Choice)","Treatment decision of investigator",[9],[32,36],{"name":33,"affiliation":34,"role":35},"Thomas Decker, Professor","Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Michael Patrick Lux, Professor","St. Louise Frauen- und Kinderklinik Paderborn",[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Laura Serrer","CONTACT","+49761152420","eleni@iomedico.com",[46,64,78],{"facility":47,"status":48,"city":49,"state":10,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Praxis für interdisziplinäre Onkologie & Hämatologie","RECRUITING","Freiburg im Breisgau","79110","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],7.85222,47.9959,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":62,"phoneExt":10,"email":63},"Patrick Marschner","+49761386870","klifo@onkologie-freiburg.de",{"facility":65,"status":48,"city":66,"state":10,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"St. Louise Frauen- und Kinderklinik","Paderborn","33098",{"type":54,"coordinates":69},[70,71],8.75439,51.71905,{"lat":71,"lon":70},[74],{"name":75,"role":42,"phone":76,"phoneExt":10,"email":77},"Michael P Lux","+49 5251864121","M.Lux@vincenz.de",{"facility":79,"status":48,"city":80,"state":10,"zip":81,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Gemeinschaftspraxis für Hämatologie und Onkologie","Ravensburg","88212",{"type":54,"coordinates":83},[84,85],9.61062,47.78198,{"lat":85,"lon":84},[88],{"name":89,"role":42,"phone":90,"phoneExt":10,"email":91},"Thomas Decker","+49 751 366197-0","thomas.decker@onkonet.eu",{"type":93,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[95],{"name":96,"class":97},"Berlin Chemie AG","UNKNOWN","100636277","elacestrant-in-patients-with-er-her2--esr1-mutated-locally-advanced-or-metastatic-breast-cancer-100636277",false,"NCT07563595","Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer","Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study","ELENI","Inclusion Criteria:\n\n* Signed and dated informed consent form\n* Postmenopausal women\n* Age ≥18 years\n* Eastern Cooperative Oncology Group Performance Status (ECOG) \\\u003C 2\n* Locally advanced and\u002For metastatic ER+ HER2- breast cancer\n* Histologically proven ER positivity (defined as ≥1% staining by immunohistochemistry (IHC))\n* Histologically proven HER2 negativity (defined as a IHC0 or IHC1+ score by IHC or a negative result by in situ hybridization (ISH), optionally combined with a IHC2+ score)\n* Disease progression following first line ET + CDKi\n* No more than one prior ET line in the advanced\u002Fmetastatic setting and intention for 2nd-line treatment with elacestrant according to current elacestrant SmPC as assessed by the treating physician (ESR1 testing can be done after inclusion)\n* For patients with proven ESR1mut: Study inclusion the latest 2 weeks after start of elacestrant treatment\n\nExclusion Criteria\n\n* Prior chemotherapy in the advanced\u002Fmetastatic setting\n* Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing.\n* Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)","FEMALE","18 Years",{"count":109,"type":110},500,"ESTIMATED","OBSERVATIONAL","The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and\u002For metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.",[114],"Breast Cancer",[22,116,117,118,119],"advanced breast cancer","Quality of life","ESR1 Mutation","Orserdu","2026-06-24",{"date":122,"type":123},"2026-06-25","ACTUAL",{"date":125,"type":123},"2026-06-19",{"date":127,"type":110},"2028-06",{"name":5,"class":6},3]