[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606833":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":21,"responsibleParty":276,"collaborators":10,"id":278,"slug":10,"hasResults":279,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":279,"sex":285,"minAge":286,"maxAge":10,"enrollmentInfo":287,"targetDuration":10,"studyType":290,"phases":10,"briefSummary":291,"conditions":292,"keywords":10,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1",null,"Patients undergoing treatment with CDK4\u002F6 inhibitors",[13],{"name":14,"affiliation":5,"role":15},"Nadia Bianco, MD","STUDY_CHAIR",[17],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+39 02 94371977","nadia.bianco@ieo.it",[22,41,57,72,87,102,117,131,143,151,163,178,193,208,223,234,249,264],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":26,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"ASST Papa Giovanni XXIII","NOT_YET_RECRUITING","Bergamo","Italy","24127",{"type":29,"coordinates":30},"Point",[31,32],9.66721,45.69601,{"lat":32,"lon":31},[35,39],{"name":36,"role":18,"phone":37,"phoneExt":10,"email":38},"Rita De Sanctis, MD","+39 035 267111","rdesanctis@asst-pg23.it",{"name":36,"role":40,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":26,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"ASST Spedali Civili di Brescia","RECRUITING","Brescia","25123",{"type":29,"coordinates":47},[48,49],10.21472,45.53558,{"lat":49,"lon":48},[52,56],{"name":53,"role":18,"phone":54,"phoneExt":10,"email":55},"Marta Laganà, MD","+39 030 3995410","marta.lagana@unibs.it",{"name":53,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":58,"status":24,"city":59,"state":26,"zip":60,"country":26,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"P.O. Antonio Perrino - ASL Brindisi","Brindisi","72100",{"type":29,"coordinates":62},[63,64],17.93607,40.63215,{"lat":64,"lon":63},[67,71],{"name":68,"role":18,"phone":69,"phoneExt":10,"email":70},"Laura Orlando, MD","+39 0831 537111","laura.orlando68@gmail.com",{"name":68,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":73,"status":43,"city":74,"state":26,"zip":75,"country":26,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"ASST Ospedale Maggiore di Crema","Crema","26013",{"type":29,"coordinates":77},[78,79],9.68176,45.36264,{"lat":79,"lon":78},[82,86],{"name":83,"role":18,"phone":84,"phoneExt":10,"email":85},"Gianluca Tomasello, MD","+39 0373280730","Gianluca.tomasello@asst-crema.it",{"name":83,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":88,"status":24,"city":89,"state":26,"zip":90,"country":26,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"ASST Lecco - PO Alessandro Manzoni","Lecco","23900",{"type":29,"coordinates":92},[93,94],9.39704,45.85589,{"lat":94,"lon":93},[97,101],{"name":98,"role":18,"phone":99,"phoneExt":10,"email":100},"Alessandra Crippa, MD","+39 03 41253000","a.crippa@asst-lecco.it",{"name":98,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":103,"status":24,"city":104,"state":26,"zip":105,"country":26,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Asst Ovest Milanese","Legnano","20025",{"type":29,"coordinates":107},[108,109],8.91506,45.59788,{"lat":109,"lon":108},[112,116],{"name":113,"role":18,"phone":114,"phoneExt":10,"email":115},"Concetta Arcanà, MD","+39 02 26433169","concetta.arcana@asst-ovestmi.it",{"name":113,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":118,"status":43,"city":119,"state":26,"zip":120,"country":26,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"IRCCS Ospedale San Raffaele","Milan","20132",{"type":29,"coordinates":122},[123,124],9.18951,45.46427,{"lat":124,"lon":123},[127,130],{"name":128,"role":18,"phone":114,"phoneExt":10,"email":129},"Luca Licata, MD","licata.luca@hsr.it",{"name":128,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":132,"status":24,"city":119,"state":26,"zip":133,"country":26,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano","20133",{"type":29,"coordinates":135},[123,124],{"lat":124,"lon":123},[138,142],{"name":139,"role":18,"phone":140,"phoneExt":10,"email":141},"Francesca Ligorio, MD","+39 0223903808","francesca.ligorio@istitutotumori.mi.it",{"name":139,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":5,"status":43,"city":119,"state":26,"zip":144,"country":26,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"20141",{"type":29,"coordinates":146},[123,124],{"lat":124,"lon":123},[149,150],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},{"name":14,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":152,"status":43,"city":119,"state":26,"zip":153,"country":26,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"PO Luigi Sacco - ASST Fatebenefratelli Sacco","20157",{"type":29,"coordinates":155},[123,124],{"lat":124,"lon":123},[158,162],{"name":159,"role":18,"phone":160,"phoneExt":10,"email":161},"Maria Silvia Cona, MD","+39 02 39042493","silvia.cona@asst-fbf-sacco.it",{"name":159,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":164,"status":24,"city":165,"state":26,"zip":166,"country":26,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Azienda Ospedaliero-Universitaria di Modena","Modena","41125",{"type":29,"coordinates":168},[169,170],10.92539,44.64783,{"lat":170,"lon":169},[173,177],{"name":174,"role":18,"phone":175,"phoneExt":10,"email":176},"Angela Toss, MD","+39 059 4222230","angelatoss@unimore.it",{"name":174,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":179,"status":43,"city":180,"state":26,"zip":181,"country":26,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Fondazione IRCCS San Gerardo dei Tintori","Monza","20900",{"type":29,"coordinates":183},[184,185],9.27246,45.58005,{"lat":185,"lon":184},[188,192],{"name":189,"role":18,"phone":190,"phoneExt":10,"email":191},"Francesca Riva, MD","+39 039 2339575","francesca.riva@irccs-sangerardo.it",{"name":189,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":194,"status":43,"city":195,"state":26,"zip":196,"country":26,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Istituto Nazionale Tumori IRCCS Fondazione G. Pascale","Naples","80131",{"type":29,"coordinates":198},[199,200],14.26811,40.85216,{"lat":200,"lon":199},[203,207],{"name":204,"role":18,"phone":205,"phoneExt":10,"email":206},"Vincenzo Di Lauro, MD","+39 081 5903111","vincenzo.dilauro@istitutotumori.na.it",{"name":204,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":209,"status":43,"city":210,"state":26,"zip":211,"country":26,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"ICS Maugeri IRCCS","Pavia","27100",{"type":29,"coordinates":213},[214,215],9.15917,45.19205,{"lat":215,"lon":214},[218,222],{"name":219,"role":18,"phone":220,"phoneExt":10,"email":221},"Barbara Tagliaferri, MD","+39 03825921","barbara.tagliaferri@icsmaugeri.it",{"name":219,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":224,"status":43,"city":210,"state":26,"zip":211,"country":26,"cosmosGeoPoint":225,"geoPoint":227,"contacts":228},"Policlinico San Matteo",{"type":29,"coordinates":226},[214,215],{"lat":215,"lon":214},[229,233],{"name":230,"role":18,"phone":231,"phoneExt":10,"email":232},"Gianpiero Rizzo, MD","+39 0382502094","g.rizzo@smatteo.pv.it",{"name":230,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":235,"status":43,"city":236,"state":26,"zip":237,"country":26,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Azienda USL IRCCS di Reggio Emilia","Reggio Emilia","42122",{"type":29,"coordinates":239},[240,241],10.63125,44.69825,{"lat":241,"lon":240},[244,248],{"name":245,"role":18,"phone":246,"phoneExt":10,"email":247},"Laura Cortesi, MD","+39 0522335111","cortesilaura67@gmail.com",{"name":245,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":250,"status":24,"city":251,"state":26,"zip":252,"country":26,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Roma","00168",{"type":29,"coordinates":254},[255,256],11.10642,44.99364,{"lat":256,"lon":255},[259,263],{"name":260,"role":18,"phone":261,"phoneExt":10,"email":262},"Luisa Carbognin, MD","+39 06 30154953","luisa.carbognin@policlinicogemelli.it",{"name":260,"role":40,"phone":10,"phoneExt":10,"email":10},{"facility":265,"status":43,"city":251,"state":26,"zip":266,"country":26,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"Ospedale Isola Tiberina - Gemelli Isola","00186",{"type":29,"coordinates":268},[255,256],{"lat":256,"lon":255},[271,275],{"name":272,"role":18,"phone":273,"phoneExt":10,"email":274},"Anna Cardillo, MD","+39 066837697","anna.cardillo@fbf-isola.it",{"name":272,"role":40,"phone":10,"phoneExt":10,"email":10},{"type":277,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100606833",false,"NCT07180693","Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4\u002F6 Inhibitors:","Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4\u002F6 Inhibitors: Evaluation in the Real-world Setting","BREAKER","Inclusion Criteria:\n\n* Female (regardless of menopausal status) or male ≥18 years of age;\n* The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4\u002F6 inhibitors (abemaciclib or ribociclib);\n* ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO\u002FCAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO\u002FCAP recommendations;\n* Patients who are initiating or have initiated adjuvant treatment with a CDK4\u002F6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Consent to data treatment according to the local regulation.\n\nExclusion Criteria:\n\n* Current participation in any other HR+\u002FHER2- EBC study with any investigational products;\n* Patients who have already received adjuvant treatment with a CDK4\u002F6 inhibitor as part of a clinical trial;\n* Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;\n* Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;\n* Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.","ALL","18 Years",{"count":288,"type":289},750,"ESTIMATED","OBSERVATIONAL","This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+\u002FHER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.",[293,294],"Adjuvant Therapy","CDK4\u002F6 Inhibitor","2026-05-28",{"date":297,"type":298},"2026-05-29","ACTUAL",{"date":300,"type":298},"2025-09-29",{"date":302,"type":289},"2030-08-01",{"name":5,"class":6},18]