[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07357298":3,"trial-entities:NCT07357298":122,"trial-summary:NCT07357298":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":42,"sex":62,"minimum_age":63,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":82,"locations":85,"central_contacts":112,"overall_officials":118,"references":120,"see_also_links":121},"NCT07357298","MCC-24030","Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer","RECRUITING","2030-02","2026-05","2026-05-15","2026-02-25","H. Lee Moffitt Cancer Center and Research Institute","OTHER",false,"This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.",null,[18],"Breast Cancer",[],"INTERVENTIONAL","SCREENING",[23],"PHASE3",{"count":25,"type":26},156,"ESTIMATED",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","Surveillance Brain MRI","Routine scheduled MRI imaging at baseline and at 6-month intervals.",[30],{"type":29,"name":34,"description":35,"armGroupLabels":36},"Standard of Care Brain Imaging","Imaging performed only when clinically indicated.",[34],[38],{"measure":39,"description":40,"timeFrame":41},"Treatment Characteristics of Brain Metastases","Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.","Up to 24 Months",[43,46,49,52,55,59],{"measure":44,"description":45,"timeFrame":41},"Frequency of Brain Metastases","The frequency of metastasis detection over the 24-month screening\u002Ffollow-up period.",{"measure":47,"description":48,"timeFrame":41},"Leptomeningeal Disease Incidence","Incidence of radiographic detection of leptomeningeal disease.",{"measure":50,"description":51,"timeFrame":41},"Brain Metastases at Diagnosis","Average number of lesions on diagnostic MRI.",{"measure":53,"description":54,"timeFrame":41},"Size of Largest Brain Metastasis","Average size of largest brain metastasis.",{"measure":56,"description":57,"timeFrame":58},"Overall Survival After Brain Metastasis Diagnosis","Time from brain metastasis diagnosis to death from any cause.","Up to 48 Months",{"measure":60,"description":61,"timeFrame":58},"Brain Metastasis Specific Survival","Time from brain metastasis diagnosis to death attributable to brain metastases.","ALL","18 Years",{"inclusion":65,"exclusion":74,"raw_text":81},[66,67,68,69,70,71,72,73],"Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status","Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+\u002FHER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.","HR+ will be defined as ER and\u002For PR \\> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO \u002F CAP Guidelines41. Triple negative will be classified as ER and PR \\\u003C10% and HER2-.","Age ≥ 18","Life expectancy ≥ 6 months","Eastern Cooperative Oncology Group performance status ≤ 2","Patients must be able to understand and the willingness to sign an informed consent for study procedures","Stated willingness to comply with all study procedures and availability for the duration of the study",[75,76,77,78,79,80],"Prior diagnosis or treatment of brain metastases or leptomeningeal disease","History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \\> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI","Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment","Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)","Contraindication towards MRI with contrast","Chronic kidney disease stage IV or V or end stage renal disease (CrCl \\\u003C30 ml\u002Fmin)","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status\n* Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+\u002FHER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.\n* HR+ will be defined as ER and\u002For PR \\> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO \u002F CAP Guidelines41. Triple negative will be classified as ER and PR \\\u003C10% and HER2-.\n* Age ≥ 18\n* Life expectancy ≥ 6 months\n* Eastern Cooperative Oncology Group performance status ≤ 2\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of brain metastases or leptomeningeal disease\n* History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \\> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI\n* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment\n* Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)\n* Contraindication towards MRI with contrast\n* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \\\u003C30 ml\u002Fmin)",[83,84],"ADULT","OLDER_ADULT",[86,102],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"Baptist Health South Florida","NOT_YET_RECRUITING","Miami","Florida","33176","United States",[94,97],{"name":95,"role":96},"Rupesh Kotecha, MD","PRINCIPAL_INVESTIGATOR",{"name":98,"role":96},"Reshma Mahtani, MD",{"lat":100,"lon":101},25.77427,-80.19366,{"facility":103,"status":7,"city":104,"state":90,"zip":105,"country":92,"contacts":106,"geoPoint":109},"Moffitt Cancer Center","Tampa","33612",[107],{"name":108,"role":96},"Kamran Ahmed, MD",{"lat":110,"lon":111},27.94752,-82.45843,[113],{"name":114,"role":115,"phone":116,"email":117},"Rheese McNab","CONTACT","813-745-1780","Rheese.McNab@moffitt.org",[119],{"name":108,"affiliation":103,"role":96},[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Breast Carcinoma",[],{"nct_id":4,"found":127,"summary":128,"prompt_version":16},true,{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is a randomized Phase III study with 156 planned participants. You would be randomly assigned to one of two groups: scheduled brain MRIs or symptom-triggered imaging.","completed","Phase III Brain MRI Surveillance for Stage IV Breast Cancer","This study is a Phase III trial for people with stage IV breast cancer. It's testing if having regular brain MRI scans (magnetic resonance imaging) every six months, called Surveillance Brain MRI, is better than only getting brain imaging when symptoms appear (Standard of Care Brain Imaging). The goal is to see if finding brain metastases (cancer spread to the brain) earlier changes how they are treated, how often they occur, if leptomeningeal disease (cancer cells in the fluid around the brain and spinal cord) develops, and impacts quality of life and survival. You can join if you are 18 or older, have stage IV breast cancer, and your cancer's ER\u002FPR\u002FHER2 status is known. The study is looking for 156 participants, but its current recruitment status is unclear.","The primary endpoint, Treatment Characteristics of Brain Metastases, is measured for up to 24 months.",128,"If you are in the surveillance group, you would have brain MRI scans at the start and then every six months. The primary endpoint is measured for up to 24 months.","Not stated in the trial record.",[30,34]]