[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655859":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":53,"studyPopulation":53,"armGroups":57,"interventions":96,"overallOfficials":102,"centralContacts":114,"locations":120,"responsibleParty":409,"collaborators":411,"id":423,"slug":424,"hasResults":425,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":425,"sex":430,"minAge":431,"maxAge":53,"enrollmentInfo":432,"targetDuration":53,"studyType":435,"phases":436,"briefSummary":437,"conditions":438,"keywords":53,"overallStatus":440,"whyStopped":53,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},{"fullName":5,"class":6},"Institut fuer Frauengesundheit","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"PO1","mutation frequency of ESR1 mutations as assessed in blood sample","Day 1",[14,17,20,23,25,28,31,34],{"measure":15,"description":16,"timeFrame":12},"SO1","ESR1 mutation frequencies according to age and BMI",{"measure":18,"description":19,"timeFrame":12},"SO2","ESR1 mutation frequencies according to type of CDK4\u002F6i therapy",{"measure":21,"description":22,"timeFrame":12},"SO3","ESR1 mutation frequencies according to type of aromatase inhibitor",{"measure":21,"description":24,"timeFrame":12},"ESR1 mutation frequencies according to menopausal status",{"measure":26,"description":27,"timeFrame":12},"SO4","ESR1 mutation frequencies according to HER2 status (HER2 0, HER2 ultralow, HER2 low)",{"measure":29,"description":30,"timeFrame":12},"SO5","ESR1 mutation frequencies according to extent of estrogen and progesterone receptor expression",{"measure":32,"description":33,"timeFrame":12},"SO6","ESR1 mutation frequencies according to tumor grading",{"measure":35,"description":36,"timeFrame":12},"SO7","ESR1 mutation frequencies according to previous therapies (de novo patients vs. previous adjuvant therapy)",[38,41,44,47],{"measure":39,"description":40,"timeFrame":12},"EO1","To explore the molecular landscape accompanying ESR1 mutations, including co-occurring genomic alterations (e.g., PIK3CA, TP53, etc.) detected in ctDNA",{"measure":42,"description":43,"timeFrame":12},"EO2","To investigate associations between ESR1 mutation characteristics (variant type, allele frequency) and clinical or molecular features, including prior AI exposure.",{"measure":45,"description":46,"timeFrame":12},"EO3","To perform transcriptomic profiling (bulk RNA-seq) of circulating immune cells (PBMCs) to identify immune activation or suppression signatures associated with clinical progression (PD vs. non-PD).",{"measure":48,"description":49,"timeFrame":12},"EO4","To explore potential biomarkers of endocrine resistance and immune modulation, integrating ctDNA muta",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":53,"timePerspective":53,"maskingInfo":55},"NA","SINGLE_GROUP",null,"DIAGNOSTIC",{"masking":56,"maskingDescription":53,"whoMasked":53},"NONE",[58,64,68,72,76,80,84,88,92],{"label":59,"type":60,"description":61,"interventionNames":62},"Cohort (0m)","EXPERIMENTAL","Before start of the 1L treatment (anticipated AI + CDK4\u002F6i)",[63],"Diagnostic Test: ESR1 testing",{"label":65,"type":60,"description":66,"interventionNames":67},"Cohort (6-8m):","Patients in months 6, 7 or 8 of the 1L treatment",[63],{"label":69,"type":60,"description":70,"interventionNames":71},"Cohort (9-11m)","Patients in months 9, 10 or 11 of the 1L treatment",[63],{"label":73,"type":60,"description":74,"interventionNames":75},"Cohort (12-14m)","Patients in months 12, 13 or 14 of the 1L treatment",[63],{"label":77,"type":60,"description":78,"interventionNames":79},"Cohort (15-17m)","Patients in months 15, 16 or 17 of the 1L treatment",[63],{"label":81,"type":60,"description":82,"interventionNames":83},"Cohort (18-20m)","Patients in months 18, 19 or 20 of the 1L treatment",[63],{"label":85,"type":60,"description":86,"interventionNames":87},"Cohort (21-23m)","Patients in months 21, 22 or 23 of the 1L treatment",[63],{"label":89,"type":60,"description":90,"interventionNames":91},"Cohort (24-26m)","Patients in months 24, 25 or 26 of the 1L treatment",[63],{"label":93,"type":60,"description":94,"interventionNames":95},"Cohort (27-29m)","Patients in months 27, 28 or 29 of the 1L treatment",[63],[97],{"type":98,"name":99,"description":100,"armGroupLabels":101,"otherNames":53},"DIAGNOSTIC_TEST","ESR1 testing","Study procedures comprise of a blood sample for ESR1 mutation testing and blood samples for translational research. ESR1 test results from a central testing facility are communicated back to the study site. Treatment of patients will continue as per discretion of the treating physician and will be documented during a single timepoint 3 months post inclusion.",[59,73,77,81,85,89,93,65,69],[103,107,111],{"name":104,"affiliation":105,"role":106},"Peter Andreas Fasching, Prof. Dr.","AGO-B e.V. c\u002Fo Frauenklinik des Universitätsklinikums Erlangen","STUDY_DIRECTOR",{"name":108,"affiliation":109,"role":110},"Volkmar Müller, Prof. Dr.","Universitätsklinikum Hamburg-Eppendorf; Klinik und Poliklinik für Gynäkologie","STUDY_CHAIR",{"name":112,"affiliation":113,"role":110},"Tanja Fehm, Prof. Dr.","Frauenklinik des Universitätsklinikums Düsseldorf",[115],{"name":116,"role":117,"phone":118,"phoneExt":53,"email":119},"Sponsor's study office","CONTACT","+49 9131 91880613","esra@ifg-erlangen.de",[121,138,151,165,178,192,205,219,233,247,261,272,286,297,311,325,339,353,367,381,395],{"facility":122,"status":53,"city":123,"state":53,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"ANregiomed gKU, AöR, Klinikum Ansbach","Ansbach","91522","Germany","DE",{"type":128,"coordinates":129},"Point",[130,131],10.5931,49.30481,{"lat":131,"lon":130},[134],{"name":135,"role":117,"phone":136,"phoneExt":53,"email":137},"Thomas Hildebrandt, PD Dr.","+49 981 484 2256","thomas.hildebrandt@anregiomed.de",{"facility":139,"status":53,"city":140,"state":53,"zip":53,"country":125,"countryCode":126,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hämato-Onkologische Praxis im Medicum; Brustzentrum","Bremen",{"type":128,"coordinates":142},[143,144],8.80717,53.07582,{"lat":144,"lon":143},[147],{"name":148,"role":117,"phone":149,"phoneExt":53,"email":150},"Ralf Meyer, Dr.","+49 421 6960960","ralfmeyer@home-bremen.com",{"facility":152,"status":53,"city":153,"state":53,"zip":154,"country":125,"countryCode":126,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Allgemeines Krankenhaus Celle; Brustzentrum","Celle","29223",{"type":128,"coordinates":156},[157,158],10.08047,52.62264,{"lat":158,"lon":157},[161],{"name":162,"role":117,"phone":163,"phoneExt":53,"email":164},"Michael Berghorn, Dr.","+49 5141 721151","michael.berghorn@akh-celle.de",{"facility":166,"status":53,"city":167,"state":53,"zip":168,"country":125,"countryCode":126,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Universitätsklinikum Carl Gustav Carus Dresden, Frauenklinik","Dresden","01307",{"type":128,"coordinates":170},[171,172],13.73832,51.05089,{"lat":172,"lon":171},[175],{"name":176,"role":117,"phone":177,"phoneExt":53,"email":53},"Theresa Link, Dr.","+49 351 4586863",{"facility":179,"status":53,"city":180,"state":53,"zip":181,"country":125,"countryCode":126,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Kostara Gyn. Onkoloy Clinic Research UG","Düsseldorf","40235",{"type":128,"coordinates":183},[184,185],6.77927,51.22319,{"lat":185,"lon":184},[188],{"name":189,"role":117,"phone":190,"phoneExt":53,"email":191},"Athina Kostara, Dr.","+49 211 53809241","athina.kostara@gynoncology-cr.de",{"facility":193,"status":53,"city":194,"state":53,"zip":195,"country":125,"countryCode":126,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Universitätsklinikum Erlangen, Frauenklinik","Erlangen","91054",{"type":128,"coordinates":197},[198,199],11.00783,49.59099,{"lat":199,"lon":198},[202],{"name":104,"role":117,"phone":203,"phoneExt":53,"email":204},"+4991318533572","peter.fasching.studien@uk-erlangen.de",{"facility":206,"status":53,"city":207,"state":53,"zip":208,"country":125,"countryCode":126,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Universitätsklinikum; Frauenheilkunde, Geburtshilfe & Reproduktionsmedizin","Homburg","66421",{"type":128,"coordinates":210},[211,212],7.33867,49.32637,{"lat":212,"lon":211},[215],{"name":216,"role":117,"phone":217,"phoneExt":53,"email":218},"Julia Radosa, Prof. Dr.","+49 6841 16280","julia.radosa@uks.eu",{"facility":220,"status":53,"city":221,"state":53,"zip":222,"country":125,"countryCode":126,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Frauenarztpraxis Baerens","Ilsede","31241",{"type":128,"coordinates":224},[225,226],10.19922,52.2634,{"lat":226,"lon":225},[229],{"name":230,"role":117,"phone":231,"phoneExt":53,"email":232},"Dirk-Toralf Baerens","+49 5172 2221","baerens@online.de",{"facility":234,"status":53,"city":235,"state":53,"zip":236,"country":125,"countryCode":126,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"OncoStudies Lörrach, Onkologie Dreiländereck","Loerrach","79539",{"type":128,"coordinates":238},[239,240],7.66457,47.61497,{"lat":240,"lon":239},[243],{"name":244,"role":117,"phone":245,"phoneExt":53,"email":246},"Gwen-Jana Töppler, Dr.","+49 7621 5791570","toeppler@onkologie-loerrach.de",{"facility":248,"status":53,"city":249,"state":53,"zip":250,"country":125,"countryCode":126,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Rotkreuzklinikum München; Brustzentrum","München","80637",{"type":128,"coordinates":252},[253,254],13.31243,51.60698,{"lat":254,"lon":253},[257],{"name":258,"role":117,"phone":259,"phoneExt":53,"email":260},"Michael Braun, Prof.","+49 89 130330","Michael.Braun@swmbrk.de",{"facility":262,"status":53,"city":249,"state":53,"zip":263,"country":125,"countryCode":126,"cosmosGeoPoint":264,"geoPoint":266,"contacts":267},"Hämatologie OnkologieMünchen Pasing MVZ GmbH","81241",{"type":128,"coordinates":265},[253,254],{"lat":254,"lon":253},[268],{"name":269,"role":117,"phone":270,"phoneExt":53,"email":271},"Matthias Zingerle, Dr.","+49 898299660","zingerle@onkolohie-pasing.de",{"facility":273,"status":53,"city":274,"state":53,"zip":275,"country":125,"countryCode":126,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"MVZ Media Vita am St. Franziskus Hospital; Frauenklinik","Münster","48145",{"type":128,"coordinates":277},[278,279],7.62571,51.96236,{"lat":279,"lon":278},[282],{"name":283,"role":117,"phone":284,"phoneExt":53,"email":285},"Christian Eichler, PD Dr.","+49 251 9355580","christian.eichler@sfh-muenster.de",{"facility":287,"status":53,"city":274,"state":53,"zip":288,"country":125,"countryCode":126,"cosmosGeoPoint":289,"geoPoint":291,"contacts":292},"Universitätsklinikum Münster; Frauenklinik","48727",{"type":128,"coordinates":290},[278,279],{"lat":279,"lon":278},[293],{"name":294,"role":117,"phone":295,"phoneExt":53,"email":296},"Opitz Carl, Dr.","+49 251 8344111","carl.opitz@ukmuenster.de",{"facility":298,"status":53,"city":299,"state":53,"zip":300,"country":125,"countryCode":126,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Klinikum Ernst von Bergmann; Frauenheilkunde","Potsdam","14467",{"type":128,"coordinates":302},[303,304],13.06566,52.39886,{"lat":304,"lon":303},[307],{"name":308,"role":117,"phone":309,"phoneExt":53,"email":310},"Dorothea Fischer, Prof. Dr.","+49 331 241 35602","Dorothea.Fischer@klinikumevb.de",{"facility":312,"status":53,"city":313,"state":53,"zip":314,"country":125,"countryCode":126,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"medicum Rosenheim MVZ GmbH; Innere Onkologie","Rosenheim","83022",{"type":128,"coordinates":316},[317,318],12.12247,47.85637,{"lat":318,"lon":317},[321],{"name":322,"role":117,"phone":323,"phoneExt":53,"email":324},"Rudolf Pihusch, Prof. Dr.","+49 803134511","Rudolf.Pihusch@pihusch.de",{"facility":326,"status":53,"city":327,"state":53,"zip":328,"country":125,"countryCode":126,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Kreiskrankenhaus Torgau; Brustzentrum","Torgau","04860",{"type":128,"coordinates":330},[331,332],12.99617,51.56016,{"lat":332,"lon":331},[335],{"name":336,"role":117,"phone":337,"phoneExt":53,"email":338},"Eike Simon, Dr.","+49 3421 77-2520","simon@kkh-torgau.de",{"facility":340,"status":53,"city":341,"state":53,"zip":342,"country":125,"countryCode":126,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Universitätsklinikum Tübingen; Department für Frauengesundheit","Tübingen","72076",{"type":128,"coordinates":344},[345,346],9.05222,48.52266,{"lat":346,"lon":345},[349],{"name":350,"role":117,"phone":351,"phoneExt":53,"email":352},"Andreas Hartkopf, Prof. Dr.","+49 7071 2982211","andreas.hartkopf@med.uni-tuebingen.de",{"facility":354,"status":53,"city":355,"state":53,"zip":356,"country":125,"countryCode":126,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Medizinische Studiengesellschaft Nord-West GmbH; Onkologie","Westerstede","26655",{"type":128,"coordinates":358},[359,360],7.92737,53.25682,{"lat":360,"lon":359},[363],{"name":364,"role":117,"phone":365,"phoneExt":53,"email":366},"Jan Janssen, Dr.","+49 4488521880","gensch-janssen@t-online.de",{"facility":368,"status":53,"city":369,"state":53,"zip":370,"country":125,"countryCode":126,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"Helios Dr. Horst Schmidt Kliniken; Gynäkologie","Wiesbaden","65199",{"type":128,"coordinates":372},[373,374],8.24435,50.08601,{"lat":374,"lon":373},[377],{"name":378,"role":117,"phone":379,"phoneExt":53,"email":380},"Michael Eichbaum, Prof. Dr.","+49 611 432377","michael.eichbaum@helios-gesundheit.de",{"facility":382,"status":53,"city":383,"state":53,"zip":384,"country":125,"countryCode":126,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"Frauenärzte am Schloß; Praxis für Gynäkologie und Geburtshilfe","Wolfenbüttel","38304",{"type":128,"coordinates":386},[387,388],10.54095,52.16442,{"lat":388,"lon":387},[391],{"name":392,"role":117,"phone":393,"phoneExt":53,"email":394},"Julia von Ehr, Dr.","+49 5331 2510","ju.vonehr@gmail.com",{"facility":396,"status":53,"city":397,"state":53,"zip":398,"country":125,"countryCode":126,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"Universitätsklinik Würzburg; Frauenklinik und Poliklinik","Würzburg","97080",{"type":128,"coordinates":400},[401,402],9.95121,49.79391,{"lat":402,"lon":401},[405],{"name":406,"role":117,"phone":407,"phoneExt":53,"email":408},"Jessica Salmen, Dr.","+49 931 20125194","salmen_J@ukw.de",{"type":410,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[412,415,417,419,421],{"name":413,"class":414},"AGO Breast (Arbeitsgemeinschaft Gynäkologische Onkologie)","UNKNOWN",{"name":416,"class":414},"data4treat GmbH",{"name":418,"class":414},"BioMedStatistics GmbH",{"name":420,"class":414},"ClinSol GmbH & Co KG",{"name":422,"class":414},"Universitätsklinikum Erlangen","100655859","esr1real-world-assessment-prevalence-study-100655859",false,"NCT07817212","ESR1Real World Assessment Prevalence Study","ESRA","Inclusion Criteria:\n\n1. Subject must be female or male and aged ≥ 18 years on the day of signing informed consent\n2. Patient has locally advanced or metastatic breast cancer not amenable to curative treatment\n3. Patient has HER2- breast cancer confirmed by local laboratory, defined as a negative in situ hybridization test or an IHC status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory)\n4. Histologically confirmed ER-positive and\u002F or PgR-positive breast cancer determined by core biopsy according to local in-house standard\n5. Patient has already initiated or is about to initiate first-line therapy with a CDK4\u002F6 inhibitor (any CDK4\u002F6i) in combination with an aromatase inhibitor (non-steroidal AI). Treatment must be intended as first-line systemic therapy for advanced or metastatic disease\n6. Information about prior oncological therapies against the HR+\u002FHER2- BC must be available\n7. Data about histo-pathological report must be available, including hormone receptor status, tumor histology, tumor grading and HER2 immunohistochemistry\n8. Inclusion in the study occurs as a single, one-time event for each patient, within one of the 9 defined cohorts\n\nExclusion Criteria:\n\n1. Patients with an interruption of ongoing first-line CDK4\u002F6i plus AI therapy exceeding 1 month for either CDK4\u002F6i or AI\n2. Patients receiving any other systemic anticancer therapy for HR+\u002FHER2- aBC, except for LHRH agonists, bisphosphonates, or denosumab\n3. Clinical evidence of progression at the timepoint of study inclusion\n4. Patients have already completed ≥ 1L of systemic therapy for aBC","ALL","18 Years",{"count":433,"type":434},1550,"ESTIMATED","INTERVENTIONAL",[51],"Many patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer in the first therapy line is endocrine sensitive. For these patients the established 1st line standard therapy is a combination of a CDK4\u002F6 inhibitor and an aromatase inhibitor. This combination therapy is usually given until clinical progression.\n\nRecent studies suggest that a detection of a somatic ESR1 mutation in the ctDNA can be clinically used to prompt an earlier change from the aromatase inhibitor to a selective estrogen receptor degrader.\n\nFor implementation in the clinical routine it is important to gain knowledge about the dynamics of ESR1 mutation in HR+\u002FHER2- advanced breast cancer patients during their first line therapy. At the beginning of the first line therapy about 5-8% of patients show an ESR1 mutation. An identification of patients with resistance to aromatase inhibitors at that timepoint might not be feasible and cost-efficient. At the timepoint of clinical progression up to 30-40% of patients will have acquired an ESR1 mutation. Knowledge about the mutation frequencies at different timepoints will be very helpful to direct testing strategies for implementing testing broadly in a population.\n\nThe aim of this study is to test ESR1 mutation frequencies in groups of patients (single time test per patient) with no clinical progression and different durations under first-line treatment with aromatase inhibitor and CDK4\u002F4 inhibitor.",[439],"HR+\u002FHER2- aBC Undergoing 1L Treatment With CDK4\u002F6i (Palbociclib, Abemaciclib or Ribociclib) and AI (Anastrozole or Letrozole)","NOT_YET_RECRUITING","2026-09-08",{"date":443,"type":444},"2026-09-14","ACTUAL",{"date":446,"type":434},"2026-10-01",{"date":448,"type":434},"2027-12-31",{"name":5,"class":6},21]