[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557935":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"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,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)","RECRUITING","Qionghai","Hainan","China","CN",{"type":39,"coordinates":40},"Point",[41,42],110.46417,19.2425,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100557935","safety-of-elacestrant-in-erher2--and-esr1-mutations-mbc-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":58,"type":59},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.",[63,64,65],"ESR1 Gene Mutation","Advanced Breast Cancer","Safety","2024-08-05",{"date":68,"type":69},"2024-08-09","ACTUAL",{"date":71,"type":69},"2024-07-13",{"date":73,"type":59},"2026-08-01",{"name":5,"class":6},1]