[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574684":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":22,"responsibleParty":43,"collaborators":10,"id":45,"slug":10,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":57,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"HR+\u002FHER2- metastatic breast cancer (mBC) patients",null,"breast",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Nicola Fusco, MD","CONTACT","00390294372079","nicola.fusco@ieo.it",{"name":19,"role":15,"phone":20,"phoneExt":10,"email":21},"francesca lombardi, biologist","00390257489425","francesca.lombardi@ieo.it",[23],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":27,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"European Institute of oncology","RECRUITING","Milan","Italy","20141","IT",{"type":31,"coordinates":32},"Point",[33,34],9.18951,45.46427,{"lat":34,"lon":33},[37,39],{"name":14,"role":15,"phone":38,"phoneExt":10,"email":17},"+300294372079",{"name":40,"role":15,"phone":41,"phoneExt":10,"email":42},"Elena Guerini Rocco, MD","+390294372871","elena.guerinirocco@ieo.it",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100574684",false,"NCT06762483","Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+\u002FHER2- Metastatic Breast Cancer (mBC) Patients,","Development and Validation of an Integrated Testing Strategy for Simultaneous Detection of ESR-1 and gBRCA Mutations Via Liquid Biopsy in HR+\u002FHER2- Metastatic Breast Cancer (mBC) Patients, and the Creation of a Digital Gene Library to Support an Evidence-based Diagnostic Algorithm","L2-268","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of estrogen receptor-positive (ER+) and\u002For progesterone receptor-positive (PgR+) breast cancer through histological and\u002For cytological examination by the local laboratory Participants must exhibit HER2-negative breast cancer\n\n  1. or 2+). If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing.\n\n     * Participants should be in an advanced or metastatic setting including both those prior to the initiation of treatment for metastatic disease and those who experienced progression following treatment with cyclin-dependent kinases (CDK)4\u002F6 inhibitors. However, the primary tumor should be treated according to the standard of care.\n     * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n\nExclusion Criteria:\n\n* Unable to provide written informed consent","FEMALE","18 Years",{"count":55,"type":56},80,"ESTIMATED","24 Months","OBSERVATIONAL","Development and validation of an integrated testing strategy for simultaneous detection of ESR-1 and gBRCA mutations via liquid biopsy in HR+\u002FHER2- metastatic breast cancer (mBC) patients, and the creation of a digital gene library to support an evidence-based diagnostic algorithm",[61],"Breast Cancer, Metastatic",[63],"HR+\u002FHER2- BRCA","2026-03-23",{"date":66,"type":67},"2026-03-24","ACTUAL",{"date":69,"type":67},"2024-12-20",{"date":71,"type":56},"2030-12-31",{"name":5,"class":6},1]