[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574257":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":46,"locations":51,"responsibleParty":198,"collaborators":34,"id":200,"slug":201,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":34,"eligibilityCriteria":206,"healthyVolunteers":202,"sex":207,"minAge":208,"maxAge":34,"enrollmentInfo":209,"targetDuration":34,"studyType":212,"phases":213,"briefSummary":215,"conditions":216,"keywords":220,"overallStatus":54,"whyStopped":34,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1A: BGB-21447 + Fulvestrant","EXPERIMENTAL","Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant.",[13,14],"Drug: BGB-21447","Drug: Fulvestrant",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 1B: BGB-21447 + BGB-43395 + Fulvestrant","Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395.",[13,14,19],"Drug: BGB-43395",{"label":21,"type":10,"description":22,"interventionNames":23},"BGB-21447 + Fulvestrant Food Effect Substudy","Participants will receive BGB-21447 at the recommended dose with a high-fat meal and under a fasted state in combination with fulvestrant.",[13,14],{"label":25,"type":10,"description":26,"interventionNames":27},"Part 2: Dose Expansion, BGB-21447 + Fulvestrant","Participants will receive BGB-21447 at the recommended dose(s) for expansion determined in Part 1A in combination with fulvestrant.",[13,14],[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","BGB-21447","Administered orally.",[21,9,16,25],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Fulvestrant","Administered via intramuscular injection.",[21,9,16,25],{"type":30,"name":40,"description":32,"armGroupLabels":41,"otherNames":34},"BGB-43395",[16],[43],{"name":44,"affiliation":5,"role":45},"Study Director","STUDY_DIRECTOR",[47],{"name":44,"role":48,"phone":49,"phoneExt":34,"email":50},"CONTACT","1.877.828.5568","clinicaltrials@beonemed.com",[52,66,76,86,98,107,117,127,136,146,158,168,178,188],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":34},"University of Iowa Hospitals and Clinics","RECRUITING","Iowa City","Iowa","52242-1009","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-91.53017,41.66113,{"lat":64,"lon":63},{"facility":67,"status":54,"city":68,"state":69,"zip":70,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":75,"contacts":34},"Md Anderson Cancer Center","Houston","Texas","77030-3907",{"type":61,"coordinates":72},[73,74],-95.36327,29.76328,{"lat":74,"lon":73},{"facility":77,"status":54,"city":78,"state":79,"zip":80,"country":58,"countryCode":59,"cosmosGeoPoint":81,"geoPoint":85,"contacts":34},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109-4433",{"type":61,"coordinates":82},[83,84],-122.33207,47.60621,{"lat":84,"lon":83},{"facility":87,"status":54,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":34},"Saint Vincents Hospital Sydney","Darlinghurst","New South Wales","NSW 2010","Australia","AU",{"type":61,"coordinates":94},[95,96],151.21925,-33.87939,{"lat":96,"lon":95},{"facility":99,"status":54,"city":100,"state":89,"zip":101,"country":91,"countryCode":92,"cosmosGeoPoint":102,"geoPoint":106,"contacts":34},"Calvary Mater Newcastle","Waratah","NSW 2298",{"type":61,"coordinates":103},[104,105],151.72647,-32.90667,{"lat":105,"lon":104},{"facility":108,"status":54,"city":109,"state":110,"zip":111,"country":91,"countryCode":92,"cosmosGeoPoint":112,"geoPoint":116,"contacts":34},"Sunshine Coast University Private Hospital","Birtinya","Queensland","QLD 4575",{"type":61,"coordinates":113},[114,115],153.11913,-26.74322,{"lat":115,"lon":114},{"facility":118,"status":54,"city":119,"state":120,"zip":121,"country":91,"countryCode":92,"cosmosGeoPoint":122,"geoPoint":126,"contacts":34},"Peter Maccallum Cancer Centre","Melbourne","Victoria","VIC 3000",{"type":61,"coordinates":123},[124,125],144.96332,-37.814,{"lat":125,"lon":124},{"facility":128,"status":54,"city":129,"state":120,"zip":130,"country":91,"countryCode":92,"cosmosGeoPoint":131,"geoPoint":135,"contacts":34},"Western Health Sunshine Hospital","St Albans","VIC 3021",{"type":61,"coordinates":132},[133,134],144.80049,-37.74496,{"lat":134,"lon":133},{"facility":137,"status":54,"city":138,"state":139,"zip":140,"country":91,"countryCode":92,"cosmosGeoPoint":141,"geoPoint":145,"contacts":34},"Linear Clinical Research","Nedlands","Western Australia","WA 6009",{"type":61,"coordinates":142},[143,144],115.8073,-31.98184,{"lat":144,"lon":143},{"facility":147,"status":54,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":34},"Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)","Guangzhou","Guangdong","510245","China","CN",{"type":61,"coordinates":154},[155,156],113.25,23.11667,{"lat":156,"lon":155},{"facility":159,"status":54,"city":160,"state":161,"zip":162,"country":151,"countryCode":152,"cosmosGeoPoint":163,"geoPoint":167,"contacts":34},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450052",{"type":61,"coordinates":164},[165,166],113.64861,34.75778,{"lat":166,"lon":165},{"facility":169,"status":54,"city":170,"state":171,"zip":172,"country":151,"countryCode":152,"cosmosGeoPoint":173,"geoPoint":177,"contacts":34},"Fudan University Shanghai Cancer Centerpudong","Shanghai","Shanghai Municipality","201321",{"type":61,"coordinates":174},[175,176],121.45806,31.22222,{"lat":176,"lon":175},{"facility":179,"status":54,"city":180,"state":181,"zip":182,"country":151,"countryCode":152,"cosmosGeoPoint":183,"geoPoint":187,"contacts":34},"Tianjin Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300060",{"type":61,"coordinates":184},[185,186],117.17667,39.14222,{"lat":186,"lon":185},{"facility":189,"status":54,"city":190,"state":191,"zip":192,"country":151,"countryCode":152,"cosmosGeoPoint":193,"geoPoint":197,"contacts":34},"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310016",{"type":61,"coordinates":194},[195,196],120.16142,30.29365,{"lat":196,"lon":195},{"type":199,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100574257","phase-1-bgb-21447-bcl-2-inhibitor-combinations-for-adults-with-hormone-receptor-positive-hrhuman-epidermal-growth-factor-receptor-2-negative-her2--metastatic-breast-cancer-100574257",false,"NCT06756932","BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer","A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+\u002FHER2- Metastatic Breast Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed HR+\u002FHER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced\u002Fmetastatic disease, including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting. Part 2: Participants must have received 1-3 prior line(s) of treatment for advanced\u002Fmetastatic disease, including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal.\n* Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n* Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 7 days after the last dose of BGB-21447, 6 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant.\n* Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal.\n\nExclusion Criteria:\n\n* Prior Bcl-2 inhibitor exposure. For triplet combination cohorts only: Prior therapy selectively targeting CDK4.\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* For Part 1B: Uncontrolled diabetes.\n* History of hepatitis B or active Hepatitis C infection\n* China Only: Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \\> 500 IU\u002Fml (or \\> 2500 copies\u002Fml) at screening.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":210,"type":211},120,"ESTIMATED","INTERVENTIONAL",[214],"PHASE1","This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia\u002Flymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+\u002FHER2- metastatic breast cancer.",[217,218,219],"Hormone-receptor-positive Breast Cancer","HER2-negative Breast Cancer","Metastatic Breast Cancer",[31,40,221,222,223],"metastatic breast cancer","Bcl-2i","CDK4i","2026-06-17",{"date":226,"type":227},"2026-06-22","ACTUAL",{"date":229,"type":227},"2025-02-04",{"date":231,"type":211},"2027-07-30",{"name":5,"class":6},14]