[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594801":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":11,"centralContacts":55,"locations":61,"responsibleParty":100,"collaborators":11,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":11,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":11,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-8080 Group","EXPERIMENTAL",null,[13],"Drug: HRS-8080 Tablet",{"label":15,"type":16,"description":11,"interventionNames":17},"Fulvestrant Group","ACTIVE_COMPARATOR",[18],"Drug: Fulvestrant injection",{"label":20,"type":16,"description":11,"interventionNames":21},"Exemestane in combination with Everolimus Group",[22,23],"Drug: Exemestane tablets","Drug: Everolimus Tablets",{"label":25,"type":16,"description":11,"interventionNames":26},"Exemestane or Anastrozole or Letrozole Group",[22,27,28],"Drug: Anastrozole Tablets","Drug: Letrozole Tablets",[30,35,39,43,47,51],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","HRS-8080 Tablet","HRS-8080 tablet orally administered.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Fulvestrant injection","Fulvestrant injection.",[15],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"Exemestane tablets","Exemestane tablets orally administered.",[20,25],{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"Everolimus Tablets","Everolimus tablets orally administered.",[20],{"type":31,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"Anastrozole Tablets","Anastrozole tablets orally administered.",[25],{"type":31,"name":52,"description":53,"armGroupLabels":54,"otherNames":11},"Letrozole Tablets","Letrozole tablets orally administered.",[25],[56],{"name":57,"role":58,"phone":59,"phoneExt":11,"email":60},"Min Li","CONTACT","+86-0518-82342973","min.li.ml150@hengrui.com",[62,84],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":71,"coordinates":72},"Point",[73,74],113.25,23.11667,{"lat":74,"lon":73},[77,81],{"name":78,"role":58,"phone":79,"phoneExt":11,"email":80},"Shusen Wang","13926168469","wangshs@sysucc.org.cn",{"name":82,"role":83,"phone":11,"phoneExt":11,"email":11},"Wang Shusen","PRINCIPAL_INVESTIGATOR",{"facility":85,"status":64,"city":86,"state":87,"zip":88,"country":68,"countryCode":69,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hunan Cancer Hospital","Changsha","Hunan","410000",{"type":71,"coordinates":90},[91,92],112.97087,28.19874,{"lat":92,"lon":91},[95,99],{"name":96,"role":58,"phone":97,"phoneExt":11,"email":98},"Quchang Ouyang","+86-0731-89762160","oyqc1969@126.com",{"name":96,"role":83,"phone":11,"phoneExt":11,"email":11},{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100594801","phase-3-a-phase-3-study-of-hrs-8080-versus-treatment-chosen-by-physicians-in-locally-advanced-and-metastatic-breast-cancer-100594801",false,"NCT07024173","A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer","A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy","Inclusion Criteria:\n\n1. Women aged 18 to 75 years old (including both values).\n2. ECOG Physical Strength Status (PS) : 0 to 1 point.\n3. Patients with locally advanced or metastatic breast cancer confirmed by histology.\n4. Patients previously received 1-2 lines of endocrine therapy.\n5. Expected survival \\> 6 months.\n6. The functional level of the organs must meet the requirements.\n7. Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.\n2. A history of severe clinical cardiovascular diseases.\n3. Patients with uncontrollable tumor-related pain as judged by investigators.\n4. Severe infection exists within 4 weeks before the first study administration.\n5. Patients with clinically significant endometrial abnormalities.\n6. Untreated active hepatitis.\n7. Patients known to be allergic to HRS-8080 components.\n8. Pregnant and lactating women, or those planning to become pregnant during the study period.","FEMALE","18 Years","75 Years",{"count":113,"type":114},240,"ESTIMATED","INTERVENTIONAL",[117],"PHASE3","This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.",[120,121],"Locally Advanced Breast Cancer","Metastatic Breast Cancer","2026-01-22",{"date":124,"type":125},"2026-01-26","ACTUAL",{"date":127,"type":125},"2025-07-23",{"date":129,"type":114},"2027-12",{"name":5,"class":6},2]