[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619780":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":52,"responsibleParty":94,"collaborators":29,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":29,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":29,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":29,"overallStatus":55,"whyStopped":29,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HRS-8080 Group","EXPERIMENTAL","HRS-8080 tablets group.",[13],"Drug: HRS-8080 Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard endocrine therapy Group","ACTIVE_COMPARATOR","Standard endocrine therapy: Letrozole tablets or Tamoxifen Citrate tablets or Anastrozole tablets or Exemestane tablets.",[19,20,21,22],"Drug: Letrozole tablets","Drug: Tamoxifen Citrate Tablets","Drug: Anastrozole Tablets","Drug: Exemestane tablets",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","HRS-8080 Tablets","HRS-8080 tablets.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Letrozole tablets","Letrozole tablets.",[15],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Tamoxifen Citrate Tablets","Tamoxifen Citrate tablets.",[15],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Anastrozole Tablets","Anastrozole tablets.",[15],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Exemestane tablets","Exemestane tablets.",[15],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Yue He","CONTACT","+86-0518-82342973","yue.he.yh58@hengrui.com",[53,74],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"The First Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210029","China","CN",{"type":62,"coordinates":63},"Point",[64,65],118.77778,32.06167,{"lat":65,"lon":64},[68,72],{"name":69,"role":49,"phone":70,"phoneExt":29,"email":71},"Qiang Ding","+86-025-68306259","q.ding@hotmail.com",{"name":69,"role":73,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"facility":75,"status":55,"city":76,"state":77,"zip":78,"country":59,"countryCode":60,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032",{"type":62,"coordinates":80},[81,82],121.45806,31.22222,{"lat":82,"lon":81},[85,89,92,93],{"name":86,"role":49,"phone":87,"phoneExt":29,"email":88},"Zhimin Shao","+86-021-64175590","szmgcp2016@163.com",{"name":90,"role":49,"phone":87,"phoneExt":29,"email":91},"Keda Yu","yukeda@163.com",{"name":86,"role":73,"phone":29,"phoneExt":29,"email":29},{"name":90,"role":73,"phone":29,"phoneExt":29,"email":29},{"type":95,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100619780","phase-3-a-phase-iii-trial-comparing-hrs-8080-with-standard-endocrine-therapy-in-patients-with-intermediate-or-high-risk-early-breast-cancer-100619780",false,"NCT07349069","A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer","A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 and ≤ 75 years. Premenopausal patients must meet the eligibility of LHRH agonist therapy during the study period.\n2. Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.\n3. No evidence of recurrent or metastatic disease after surgery.\n4. ECOG performance status of 0 or 1.\n5. Adequate organ and bone marrow function.\n6. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug.\n7. Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).\n8. The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Tumor clinical stage IV (metastatic) breast cancer.\n2. History and\u002For treatment of any malignancy other than breast cancer within 5 years prior to randomization.\n3. History of severe pulmonary disease, such as interstitial lung disease.\n4. Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.\n5. Major surgical procedure within 4 weeks prior to randomization.\n6. HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.\n7. Poor cardiac function.\n8. Severe infection within 4 weeks prior to randomization.\n9. History of drug allergy.\n10. History of organ transplantation.\n11. History of substance abuse.\n12. Women within 1 year postpartum or who are currently breastfeeding.\n13. Patients deemed by the investigator as unsuitable for participation in this study.","FEMALE","18 Years","75 Years",{"count":107,"type":108},5500,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.",[114],"Breast Cancer","2026-05-18",{"date":117,"type":118},"2026-05-22","ACTUAL",{"date":120,"type":118},"2026-03-04",{"date":122,"type":108},"2034-01",{"name":5,"class":6},2]