[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619780":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":16,"studyPopulation":16,"armGroups":28,"interventions":44,"overallOfficials":16,"centralContacts":66,"locations":72,"responsibleParty":114,"collaborators":16,"id":116,"slug":16,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":16,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":16,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":16,"overallStatus":75,"whyStopped":16,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.","Invasive Breast Cancer-Free Survival (IBCFS).","At Week 24, Week 56, Week 80, and Week 104 during the initial 104-week period, and then every 52 weeks thereafter, up to 5 years.",[14,17,19],{"measure":15,"description":16,"timeFrame":12},"Invasive Disease-Free Survival (IDFS).",null,{"measure":18,"description":16,"timeFrame":12},"Distant Metastasis-Free Survival (DRFS).",{"measure":20,"description":16,"timeFrame":21},"Overall Survival (OS).","Survival follow-up every 3 months, up to 5 years.",{"allocation":23,"interventionModel":24,"interventionModelDescription":16,"primaryPurpose":25,"observationalModel":16,"timePerspective":16,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":16,"whoMasked":16},"NONE",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"HRS-8080 Group","EXPERIMENTAL","HRS-8080 tablets group.",[34],"Drug: HRS-8080 Tablets",{"label":36,"type":37,"description":38,"interventionNames":39},"Standard endocrine therapy Group","ACTIVE_COMPARATOR","Standard endocrine therapy: Letrozole tablets or Tamoxifen Citrate tablets or Anastrozole tablets or Exemestane tablets.",[40,41,42,43],"Drug: Letrozole tablets","Drug: Tamoxifen Citrate Tablets","Drug: Anastrozole Tablets","Drug: Exemestane tablets",[45,50,54,58,62],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":16},"DRUG","HRS-8080 Tablets","HRS-8080 tablets.",[30],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":16},"Letrozole tablets","Letrozole tablets.",[36],{"type":46,"name":55,"description":56,"armGroupLabels":57,"otherNames":16},"Tamoxifen Citrate Tablets","Tamoxifen Citrate tablets.",[36],{"type":46,"name":59,"description":60,"armGroupLabels":61,"otherNames":16},"Anastrozole Tablets","Anastrozole tablets.",[36],{"type":46,"name":63,"description":64,"armGroupLabels":65,"otherNames":16},"Exemestane tablets","Exemestane tablets.",[36],[67],{"name":68,"role":69,"phone":70,"phoneExt":16,"email":71},"Yue He","CONTACT","+86-0518-82342973","yue.he.yh58@hengrui.com",[73,94],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"The First Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210029","China","CN",{"type":82,"coordinates":83},"Point",[84,85],118.77778,32.06167,{"lat":85,"lon":84},[88,92],{"name":89,"role":69,"phone":90,"phoneExt":16,"email":91},"Qiang Ding","+86-025-68306259","q.ding@hotmail.com",{"name":89,"role":93,"phone":16,"phoneExt":16,"email":16},"PRINCIPAL_INVESTIGATOR",{"facility":95,"status":75,"city":96,"state":97,"zip":98,"country":79,"countryCode":80,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032",{"type":82,"coordinates":100},[101,102],121.45806,31.22222,{"lat":102,"lon":101},[105,109,112,113],{"name":106,"role":69,"phone":107,"phoneExt":16,"email":108},"Zhimin Shao","+86-021-64175590","szmgcp2016@163.com",{"name":110,"role":69,"phone":107,"phoneExt":16,"email":111},"Keda Yu","yukeda@163.com",{"name":106,"role":93,"phone":16,"phoneExt":16,"email":16},{"name":110,"role":93,"phone":16,"phoneExt":16,"email":16},{"type":115,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","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":126,"type":127},5500,"ESTIMATED","INTERVENTIONAL",[130],"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.",[133],"Breast Cancer","2026-05-18",{"date":136,"type":137},"2026-05-22","ACTUAL",{"date":139,"type":137},"2026-03-04",{"date":141,"type":127},"2034-01",{"name":5,"class":6},2]