[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602264":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":139,"collaborators":25,"id":141,"slug":25,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":25,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":25,"enrollmentInfo":149,"targetDuration":25,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Radionetics Oncology","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: 68Ga-R11228 Dose Optimization Portion","EXPERIMENTAL","68Ga-R11228 injection at pre-defined dose levels.",[13],"Drug: 68Ga-R11228",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: 68Ga-R11228 Imaging and 177Lu-R11228 Dose Ranging Portion","68Ga-R11228 injection at pre-defined dose. 177Lu-R11228 injection at pre-defined doses.",[13,18],"Drug: 177Lu-R11228",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","68Ga-R11228","68Ga-R11228 is a gallium-labeled small molecule radioligand that is designed to localize tumor lesions",[9,15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"177Lu-R11228","177Lu-R11228 is a lutetium-labeled small molecule radioligand designed to treat tumor lesions",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Kristrun Stardal","CONTACT","8582186617","kstardal@radionetics.com",[37,55,70,82,97,112,126],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Indiana University Melvin and Bren Simon Cancer Center","RECRUITING","Indianapolis","Indiana","46202","United States",{"type":45,"coordinates":46},"Point",[47,48],-86.15804,39.76838,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Xin Bryan","317 274 5495","zhongx@iu.edu",{"facility":56,"status":39,"city":57,"state":58,"zip":59,"country":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"United Theranostics","Glen Burnie","Maryland","21061",{"type":45,"coordinates":61},[62,63],-76.62469,39.16261,{"lat":63,"lon":62},[66],{"name":67,"role":33,"phone":68,"phoneExt":25,"email":69},"Amanda Huggins","667-HOPENOW","clinicaltrial@unithera.com",{"facility":71,"status":39,"city":72,"state":73,"zip":74,"country":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"United Theranostics Princeton","Princeton","New Jersey","08540",{"type":45,"coordinates":76},[77,78],-74.65905,40.34872,{"lat":78,"lon":77},[81],{"name":67,"role":33,"phone":68,"phoneExt":25,"email":69},{"facility":83,"status":39,"city":84,"state":85,"zip":86,"country":43,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University Hospital Seidman Cancer Center","Cleveland","Ohio","44106",{"type":45,"coordinates":88},[89,90],-81.69541,41.4995,{"lat":90,"lon":89},[93],{"name":94,"role":33,"phone":95,"phoneExt":25,"email":96},"Alberto Montero","(216) 844-3951","Alberto.Montero@UHhospitals.org",{"facility":98,"status":39,"city":99,"state":100,"zip":101,"country":43,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":45,"coordinates":103},[104,105],-95.36327,29.76328,{"lat":105,"lon":104},[108],{"name":109,"role":33,"phone":25,"phoneExt":110,"email":111},"Nathan Comeaux","(832) 728-0689","NIComeaux@mdanderson.org",{"facility":113,"status":39,"city":114,"state":115,"zip":116,"country":43,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"University of Utah - Huntsman Cancer Institute","Salt Lake City","Utah","84112",{"type":45,"coordinates":118},[119,120],-111.89105,40.76078,{"lat":120,"lon":119},[123],{"name":124,"role":33,"phone":25,"phoneExt":25,"email":125},"Blake Nordblad","blake.nordblad@hci.utah.edu",{"facility":127,"status":39,"city":128,"state":25,"zip":25,"country":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Melbourne Theranostic Innovation Centre (MTIC)","Melbourne","Australia",{"type":45,"coordinates":131},[132,133],144.96332,-37.814,{"lat":133,"lon":132},[136],{"name":137,"role":33,"phone":25,"phoneExt":25,"email":138},"Chistopher Marinakis","cmarinakis@mtic.net.au",{"type":140,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100602264",false,"NCT07121244","A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer","Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Patients With Advanced Breast Cancer","Inclusion Criteria:\n\nPart A\n\n* Pathologically confirmed estrogen and\u002For progesterone receptor (ER\u002FPR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer\n* At least one target or non-target lesion per RECIST v1.1 criteria.\n* Male or non-pregnant, non-lactating female subjects age ≥18 years.\n\nPart B\n\n* Pathologically confirmed estrogen and\u002For progesterone receptor (ER\u002FPR) positive and HER2 negative locoregionally recurrent or metastatic breast cancer\n* Refractory to endocrine therapy. Note: there is no limit on prior number of lines of endocrine therapy or prior treatments with CDK4\u002F6, AKT, PI3K and\u002For mTOR inhibitors.\n* Received or declined at least one line of chemotherapy or antibody drug conjugate in the locoregionally recurrent or metastatic setting\n* Progressive disease or intolerance to last treatment.\n* At least one target lesion per RECIST v1.1 criteria.\n* Male or non-pregnant, non-lactating female subjects age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least six months.\n* Adequate bone marrow reserve, hepatic function and renal function.\n\nExclusion Criteria:\n\nPart A\n\n* Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy\u002Fintervention.\n* Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\]) during the screening period.\n* Radiotherapy for breast cancer ≤ 28 days prior\n* Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228.\n* Any condition that precludes the proper performance of imaging procedures required in this study.\n\nPart B\n\n* Study participant has not recovered from clinically significant adverse event(s) resulting from most recent anticancer therapy\u002Fintervention\n* Treatment with anticancer therapy or with an investigational drug or device within 21 days or 5 half-lives of the agent (whichever is shorter)\n* Known central nervous system (CNS) disease, except for those subjects with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\]) during the screening period.\n* Radiotherapy for breast cancer ≤ 28 days\n* Prior systemic radionuclide therapeutic treatment.\n* Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R11228.\n* Any unresolved NCI-CTCAE Version 5.0 Grade 2 or higher toxicity (except alopecia and Grade 2 platinum-therapy related neuropathy) from previous breast cancer treatment and\u002For from medical\u002Fsurgical procedures or interventions.\n* Any condition that precludes the proper performance of imaging procedures required in this study.","ALL","18 Years",{"count":150,"type":151},62,"ESTIMATED","INTERVENTIONAL",[154],"PHASE1","A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.",[157,158],"Locoregionally Recurrent Hormone-receptor Positive Breast Cancer","Metastatic Hormone Receptor Positive Breast Cancer",[160,161,162],"Hormone Receptor Positive Breast Cancer","Endocrine resistant","Radioisotope","2026-04-08",{"date":165,"type":166},"2026-04-13","ACTUAL",{"date":168,"type":166},"2025-10-01",{"date":170,"type":151},"2033-06-01",{"name":5,"class":6},7]