[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557935":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":45,"collaborators":10,"id":47,"slug":10,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"SciClone Pharmaceuticals","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ELacestrant",null,"Subjects in this cohort will receive elacestrant",[13],"Drug: ELacestrant",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","345 mg\u002Fday once daily oral dosing",[9],[20],{"name":21,"affiliation":22,"role":23},"Qing Qu, Doctor","Ruijin Hospital","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Chunyang Li, Doctor","CONTACT","86-15216717343","lichunyang@sciclone.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":10,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)","RECRUITING","Qionghai","Hainan","China",{"type":38,"coordinates":39},"Point",[40,41],110.46417,19.2425,{"lat":41,"lon":40},[44],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":46,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100557935",false,"NCT06544577","Safety of Elacestrant in ER+\u002FHER2- and ESR1 Mutations MBC","Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+\u002FHER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study","Inclusion Criteria:\n\n* 1\\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.\n* 2\\. female ≥ 18 years of age\n* 3\\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \\\u003C age ≤ 60 years old with 1 year of menopause. d) Age \\\u003C60 years and receiving ovarian suppression therapy.\n* 4\\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.\n* 5\\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.\n* 6\\. have normal organ function (as assessed by the investigator).\n\nExclusion Criteria:\n\n* 1\\. women who are pregnant or breastfeeding\n* 2\\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements\n* 3\\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator","FEMALE","18 Years",{"count":56,"type":57},350,"ESTIMATED","OBSERVATIONAL","This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+\u002FHER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.",[61,62,63],"ESR1 Gene Mutation","Advanced Breast Cancer","Safety","2024-08-05",{"date":66,"type":67},"2024-08-09","ACTUAL",{"date":69,"type":67},"2024-07-13",{"date":71,"type":57},"2026-08-01",{"name":5,"class":6},1]