[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468215":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":103,"centralContacts":107,"locations":108,"responsibleParty":130,"collaborators":132,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":107,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":107,"enrollmentInfo":145,"targetDuration":107,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":107,"overallStatus":110,"whyStopped":107,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment ( 64Cu-DOTA-trastuzumab PET\u002FMRI)","EXPERIMENTAL","Patients receive trastuzumab IV over 15 minutes on day 0. Patients then receive 64Cu-DOTA-trastuzumab IV and then undergo PET\u002FMRI scan on day 1. Patients undergo repeat brain MRI every 6 weeks for 24 weeks and then every 9 weeks until disease progression. Patients then receive trastuzumab deruxtecan IV every 21 days in the absence of disease progression or unacceptable toxicity.",[13,14,15,16,17],"Other: Copper Cu 64-DOTA-Trastuzumab","Procedure: Magnetic Resonance Imaging","Device: Positron Emission Tomography","Biological: Trastuzumab","Biological: Trastuzumab Deruxtecan",[19,25,40,51,94],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Copper Cu 64-DOTA-Trastuzumab","Given IV",[9],[24],"64Cu-DOTA-Trastuzumab",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Magnetic Resonance Imaging","Undergo PET\u002FMRI",[9],[31,32,33,34,35,36,37,38,39],"Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":41,"name":42,"description":28,"armGroupLabels":43,"otherNames":44},"DEVICE","Positron Emission Tomography",[9],[45,46,47,48,49,50],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging",{"type":52,"name":53,"description":21,"armGroupLabels":54,"otherNames":55},"BIOLOGICAL","Trastuzumab",[9],[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"ABP 980","ALT02","Anti-c-ERB-2","Anti-c-erbB2 Monoclonal Antibody","Anti-ERB-2","Anti-erbB-2","Anti-erbB2 Monoclonal Antibody","Anti-HER2\u002Fc-erbB2 Monoclonal Antibody","Anti-p185-HER2","c-erb-2 Monoclonal Antibody","HER2 Monoclonal Antibody","Herceptin","Herceptin Biosimilar PF-05280014","Herceptin Trastuzumab Biosimilar PF-05280014","Herzuma","Kanjinti","MoAb HER2","Monoclonal Antibody c-erb-2","Monoclonal Antibody HER2","Ogivri","Ontruzant","PF-05280014","rhuMAb HER2","RO0452317","SB3","Trastuzumab Biosimilar ABP 980","Trastuzumab Biosimilar ALT02","trastuzumab biosimilar EG12014","Trastuzumab Biosimilar HLX02","Trastuzumab Biosimilar PF-05280014","Trastuzumab Biosimilar SB3","Trastuzumab Biosimilar SIBP-01","Trastuzumab-anns","Trastuzumab-dkst","Trastuzumab-dttb","Trastuzumab-pkrb","Trastuzumab-qyyp","Trazimera",{"type":52,"name":95,"description":21,"armGroupLabels":96,"otherNames":97},"Trastuzumab Deruxtecan",[9],[98,99,100,101,102],"DS-8201","DS-8201a","Enhertu","Fam-trastuzumab Deruxtecan-nxki","WHO 10516",[104],{"name":105,"affiliation":5,"role":106},"Joanne E Mortimer","PRINCIPAL_INVESTIGATOR",null,[109],{"facility":5,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"RECRUITING","Duarte","California","91010","United States","US",{"type":117,"coordinates":118},"Point",[119,120],-117.97729,34.13945,{"lat":120,"lon":119},[123,129],{"name":124,"role":125,"phone":126,"phoneExt":127,"email":128},"Joanne E. Mortimer","CONTACT","626-256-4673","81218","jmortimer@coh.org",{"name":124,"role":106,"phone":107,"phoneExt":107,"email":107},{"type":131,"investigatorFullName":107,"investigatorTitle":107,"investigatorAffiliation":107,"oldNameTitle":107,"oldOrganization":107},"SPONSOR",[133],{"name":134,"class":135},"National Cancer Institute (NCI)","NIH","100468215","phase-4-an-investigational-scan-64cu-dota-trastuzumab-petmri-in-imaging-patients-with-her2-breast-cancer-with-brain-metastasis-100468215",false,"NCT05376878","An Investigational Scan (64Cu-DOTA-Trastuzumab PET\u002FMRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis","Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \\[ASCO\\] College of American Pathologist \\[CAP\\] guidelines) who have brain metastases\n* Age \\> 18 years\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Patients with leptomeningeal disease will be considered eligible\n* Planned therapy with fam-trastuzumab deruxtecan\n* Left ventricular ejection fraction (LVEF) \\> 50%\n* Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9\u002FL\n* Platelets \\> 100 x 10\\^9\u002FL\n* Hemoglobin \\> 9 g\u002FdL\n* Total (T.) bilirubin \\\u003C 3 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* Creatinine clearance \\> 30 ml\u002Fmin (by Cockcroft-Gault formula)\n* Activated partial thromboplastin time (aPTT) \\\u003C 1.5 x ULN\n* Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \\> 1.5 cm is evident on MRI\n\nExclusion Criteria:\n\n* Need for immediate local intervention for brain metastases\n* Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids\n* Clinically significant corneal disease\n* Myocardial infarction \\\u003C 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia","ALL","18 Years",{"count":146,"type":147},10,"ESTIMATED","INTERVENTIONAL",[150],"PHASE4","This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET\u002FMRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).",[153,154,155],"Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","Metastatic Malignant Neoplasm in the Brain","2026-06-29",{"date":158,"type":159},"2026-07-01","ACTUAL",{"date":161,"type":159},"2022-12-21",{"date":163,"type":147},"2027-04-27",{"name":5,"class":6},1]