[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558269":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":10,"id":50,"slug":10,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"SciClone Pharmaceuticals","INDUSTRY",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Chemotherapy",null,[12],"Drug: Endocrine therapy",{"label":14,"type":10,"description":10,"interventionNames":15},"Endocrine therapy",[16],"Drug: Chemotherapy Prednisone",[18,22],{"type":19,"name":14,"description":20,"armGroupLabels":21,"otherNames":10},"DRUG","All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.",[9],{"type":19,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"Chemotherapy Prednisone","All chemotherapy treatment regimens approved for advanced breast cancer",[14],[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Chunyang Li","CONTACT","86-15216717343","lichunyang@sciclone.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":10,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Tianjin Haidafu Internet Hospital","RECRUITING","Suzhou","Jiangsu","China",{"type":40,"coordinates":41},"Point",[42,43],120.59538,31.30408,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":30,"phoneExt":10,"email":31},"Chunyang Li, Doctor",{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100558269",false,"NCT06548919","Current Status of Treatment for Chinese Patients With ESR1-mutated HR+\u002FHER2-advanced Breast Cancer","Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+\u002FHER2-advanced Breast Cancer After Failure of Prior 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":59,"type":60},450,"ESTIMATED","OBSERVATIONAL","This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+\u002FHER2-advanced breast cancer after failure of endocrine therapy.\n\nEpidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation\u002Fwithdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.",[64,65],"ESR1 Gene Mutation","Advanced Breast Cancer","2024-08-07",{"date":68,"type":69},"2024-08-12","ACTUAL",{"date":71,"type":69},"2024-08-08",{"date":73,"type":60},"2027-12-31",{"name":5,"class":6},1]