[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602264":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":141,"collaborators":25,"id":143,"slug":25,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":25,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":25,"enrollmentInfo":151,"targetDuration":25,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"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",[37,56,71,83,98,113,127],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Indiana University Melvin and Bren Simon Cancer Center","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-86.15804,39.76838,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":55},"Xin Bryan","317 274 5495","zhongx@iu.edu",{"facility":57,"status":39,"city":58,"state":59,"zip":60,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"United Theranostics","Glen Burnie","Maryland","21061",{"type":46,"coordinates":62},[63,64],-76.62469,39.16261,{"lat":64,"lon":63},[67],{"name":68,"role":33,"phone":69,"phoneExt":25,"email":70},"Amanda Huggins","667-HOPENOW","clinicaltrial@unithera.com",{"facility":72,"status":39,"city":73,"state":74,"zip":75,"country":43,"countryCode":44,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"United Theranostics Princeton","Princeton","New Jersey","08540",{"type":46,"coordinates":77},[78,79],-74.65905,40.34872,{"lat":79,"lon":78},[82],{"name":68,"role":33,"phone":69,"phoneExt":25,"email":70},{"facility":84,"status":39,"city":85,"state":86,"zip":87,"country":43,"countryCode":44,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University Hospital Seidman Cancer Center","Cleveland","Ohio","44106",{"type":46,"coordinates":89},[90,91],-81.69541,41.4995,{"lat":91,"lon":90},[94],{"name":95,"role":33,"phone":96,"phoneExt":25,"email":97},"Alberto Montero","(216) 844-3951","Alberto.Montero@UHhospitals.org",{"facility":99,"status":39,"city":100,"state":101,"zip":102,"country":43,"countryCode":44,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":46,"coordinates":104},[105,106],-95.36327,29.76328,{"lat":106,"lon":105},[109],{"name":110,"role":33,"phone":25,"phoneExt":111,"email":112},"Nathan Comeaux","(832) 728-0689","NIComeaux@mdanderson.org",{"facility":114,"status":39,"city":115,"state":116,"zip":117,"country":43,"countryCode":44,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University of Utah - Huntsman Cancer Institute","Salt Lake City","Utah","84112",{"type":46,"coordinates":119},[120,121],-111.89105,40.76078,{"lat":121,"lon":120},[124],{"name":125,"role":33,"phone":25,"phoneExt":25,"email":126},"Blake Nordblad","blake.nordblad@hci.utah.edu",{"facility":128,"status":39,"city":129,"state":25,"zip":25,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Melbourne Theranostic Innovation Centre (MTIC)","Melbourne","Australia","AU",{"type":46,"coordinates":133},[134,135],144.96332,-37.814,{"lat":135,"lon":134},[138],{"name":139,"role":33,"phone":25,"phoneExt":25,"email":140},"Chistopher Marinakis","cmarinakis@mtic.net.au",{"type":142,"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":152,"type":153},62,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.",[159,160],"Locoregionally Recurrent Hormone-receptor Positive Breast Cancer","Metastatic Hormone Receptor Positive Breast Cancer",[162,163,164],"Hormone Receptor Positive Breast Cancer","Endocrine resistant","Radioisotope","2026-04-08",{"date":167,"type":168},"2026-04-13","ACTUAL",{"date":170,"type":168},"2025-10-01",{"date":172,"type":153},"2033-06-01",{"name":5,"class":6},7]