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Mokdong Hospital","07985",{"type":61,"coordinates":302},[289,290],{"lat":290,"lon":289},{"facility":305,"status":54,"city":306,"state":281,"zip":307,"country":247,"countryCode":29,"cosmosGeoPoint":29,"geoPoint":29,"contacts":29},"Asan Medical Center","SongpaGu","05505",{"type":309,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100630820","phase-3-bgb-43395-plus-letrozole-versus-cdk46i-plus-letrozole-for-patients-with-advanced-or-metastatic-hrher2--breast-cancer-who-have-not-received-prior-treatment-for-advanced-or-metastatic-disease-100630820",false,"NCT07492641","BGB-43395 Plus Letrozole Versus CDK4\u002F6i Plus Letrozole for Patients With Advanced or Metastatic HR+\u002FHER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease","An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4\u002F6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+\u002FHER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease","KANDELA-302","Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.\n* Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Participants who have received prior systemic treatment in the advanced or metastatic setting.\n* Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":321,"type":322},1056,"ESTIMATED","INTERVENTIONAL",[325],"PHASE3","The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.",[328],"HR+\u002FHER2- Breast Cancer",[330,331],"CDK4 inhibitor","CDK4\u002F6 inhibitor","2026-06-17",{"date":334,"type":335},"2026-06-18","ACTUAL",{"date":337,"type":335},"2026-05-22",{"date":339,"type":322},"2037-08-07",{"name":5,"class":6},30]