[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-sensitive-metastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-sensitive-metastatic-breast-cancer":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100561491","phase-1-trial-of-225ac-dotatate-ryz101-in-subjects-with-er-her2-negative-unresectable-or-metastatic-breast-cancer-expressing-sstrs-100561491",false,"NCT06590857","Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.","Phase 1b\u002F2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects With Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) (TRACY-1).","TRACY-1","Inclusion Criteria\n\nSubjects must meet all the following criteria for enrollment in the study:\n\n* Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent.\n* Adequate renal, hematologic, and hepatic function\n* Additional inclusion criteria for Monotherapy arm:\n\n  * Measurable disease with at least 80% SSTR-positive lesions by SSTR-PET imaging\n  * Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n  * Documented radiologic progression after at least 2 and no more than 4 prior chemotherapy or ADC regimens in the metastatic setting\n* Additional inclusion criteria for ET Combination arms:\n\n  * Prior treatment with CDK4\u002F6 inhibitors in combination with endocrine therapy in the advanced or metastatic setting.\n  * Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n  * Bone only or bone dominant disease. At least 1 bone lesion must be SSTR-positive on SSTR-PET imaging. For bone dominant disease, at least 50% of soft tissue measurable lesions must be SSTR-positive on SSTR-PET imaging. At least one bone lesion must be positive on both SSTR-PET and on FDG-PET imaging\n  * Brain metastases are allowed if definitively treated and clinically stable as confirmed by interval imaging\n\nExclusion Criteria\n\nSubjects who meet any of the following criteria will be excluded from the study:\n\n* Prior radiopharmaceutical therapy, including radioembolization.\n* Any toxicities from prior treatments that have not recovered to CTCAE Grade ≤1, except for alopecia.\n* Significant cardiovascular disease\n* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.\n* History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.\n* Pregnancy or breastfeeding\n* Additional exclusion criteria for ET Combination arms:\n\n  * Presence of liver metastases or symptomatic metastatic visceral disease\n  * Prior PARPi exposure or are candidates for PARPi per local guidelines","ALL",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Phase 1b\u002F2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.",[27,28,29,30,31,32,33,34,35,36],"Metastatic Breast Cancer","HER2-negative Breast Cancer","ER+ Breast Cancer","Advanced Breast Cancer","Metastatic Breast Cancer With Bone Involvement","Bone Metastases in Subjects With Advanced Breast Cancer","ER-Positive HER2-Negative Breast Cancer","Estrogen Receptor-positive Breast Cancer","Hormone-sensitive Metastatic Breast Cancer","Hormone-Sensitive Breast Cancer",[38,39,40,41,42,43,44,45,46,47],"Actinium","Alpha-Emitter","SSTR+ MBC","ER+, HER2-, MBC","RYZ101","225Ac","Targeted Radiotherapy","Radiopharmaceutical","SSTR+ ABC","ER+, HER2-, ABC","RECRUITING","2026-10-02",{"date":51,"type":52},"2026-10-06","ACTUAL",{"date":54,"type":52},"2024-07-19",{"date":56,"type":20},"2033-11",{"name":58,"class":59},"RayzeBio, Inc.","INDUSTRY",31]