[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04030507":3,"trial-entities:NCT04030507":140,"trial-summary:NCT04030507":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":44,"secondary_outcomes":56,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":109,"locations":112,"central_contacts":130,"overall_officials":136,"references":138,"see_also_links":139},"NCT04030507","19-066","Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer","Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First\u002FSecond Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study","RECRUITING","2028-02","2026-03","2026-03-19","2019-07-26","Brigham and Women's Hospital","OTHER",true,"This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).","This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease.\n\nIn this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed.\n\nThis trial will contain 4 cohorts:\n\n1\\. Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study\n\n2+3. Those with hormone receptor positive\u002F(human epidermal growth factor receptor 2 (HER2) negative (HR+\u002FHER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening.\n\n4\\. Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.",[19,20,21,22,23,24],"Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Inflammatory Breast Cancer","Metastatic Breast Cancer",[19,20,21,22,23,26],"Metastatic breast cancer","INTERVENTIONAL","SCREENING",[30],"NA",{"count":32,"type":33},214,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":42},"DEVICE","MRI","MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).",[40,41,21],"HR+ or HER2+ Metastatic Breast Cancer - Screening Arm","Inflammatory Breast Cancer Managed with Curative Intent",[43],"Magnetic Resonance Imaging",[45,49,53],{"measure":46,"description":47,"timeFrame":48},"Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module","For patients with HR+\u002FHER2- or HER2+ metastatic breast cancer","12 Months",{"measure":50,"description":51,"timeFrame":52},"Incidence of Symptomatic Brain Metastases","For patients with triple negative metastatic breast cancer","Through study completion, an average of 1 year",{"measure":54,"description":55,"timeFrame":52},"Incidence of Brain Metastases","For patients with inflammatory breast cancer managed with curative intent",[57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87],{"measure":58,"timeFrame":52},"Number of brain metastases",{"measure":60,"timeFrame":52},"Size of brain metastases",{"measure":62,"timeFrame":52},"Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain",{"measure":64,"timeFrame":52},"Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain",{"measure":66,"timeFrame":52},"Radiographic appearance of brain metastases",{"measure":68,"timeFrame":52},"Development of symptomatic brain metastases based on review of medical notes \u002F history",{"measure":70,"timeFrame":52},"Neurologic death",{"measure":72,"timeFrame":52},"All-cause mortality",{"measure":74,"timeFrame":52},"Development of seizures based on review of medical notes \u002F history",{"measure":76,"timeFrame":52},"Receipt of whole brain radiation due to brain metastases",{"measure":78,"timeFrame":52},"Receipt of neurosurgical resection due to brain metastases",{"measure":80,"timeFrame":52},"Quality of life assessment via EuroQol Group 5D Instrument",{"measure":82,"timeFrame":52},"Neurocognitive function using the Hopkins Verbal Learning Test Instrument",{"measure":84,"timeFrame":52},"Neurocognitive function using the Trail Making Test Instrument",{"measure":86,"timeFrame":52},"Neurocognitive function using the Controlled Oral Word Association Test",{"measure":88,"timeFrame":52},"Neurocognitive function using the Mini-Mental Status Exam Instrument","ALL","18 Years",null,false,{"inclusion":94,"exclusion":102,"raw_text":108},[95,96,97,98,99,100,101],"Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and\u002For study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.","Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic\u002Frecurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.","Participants must be age 18 years or older.","Participants must have a life expectancy of greater than 12 weeks.","Participants must be willing to undergo study procedures.","The effects of gadolinium \u002F other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.","Participants must possess the ability to understand and the willingness to sign a written informed consent document.",[103,104,105,106,107],"Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).","Participants who have chronic kidney disease stage IV-V or end stage renal disease.","Participants with a history of anaphylactic reactions to gadolinium.","Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.","Patients with a prior diagnosis of brain metastases","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and\u002For study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.\n* Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic\u002Frecurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.\n* Participants must be age 18 years or older.\n* Participants must have a life expectancy of greater than 12 weeks.\n* Participants must be willing to undergo study procedures.\n* The effects of gadolinium \u002F other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n* Participants must possess the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).\n* Participants who have chronic kidney disease stage IV-V or end stage renal disease.\n* Participants with a history of anaphylactic reactions to gadolinium.\n* Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.\n* Patients with a prior diagnosis of brain metastases",[110,111],"ADULT","OLDER_ADULT",[113],{"facility":13,"status":8,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":127},"Boston","Massachusetts","02115","United States",[119,124],{"name":120,"role":121,"phone":122,"email":123},"Ayal Aizer","CONTACT","617-732-7560","aaaizer@partners.org",{"name":125,"role":126},"Ayal Aizer, MD, MHS","PRINCIPAL_INVESTIGATOR",{"lat":128,"lon":129},42.35843,-71.05977,[131,132],{"name":125,"role":121,"phone":122,"email":123},{"name":133,"role":121,"phone":134,"email":135},"Ivy Ricca, BA","6175828927","iricca@mgb.org",[137],{"name":125,"affiliation":13,"role":126},[],[],{"nct_id":4,"conditions":141,"biomarkers":143},[142],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":145,"prompt_version":155},{"design":146,"status":147,"heading":148,"summary":149,"follow_up":150,"word_count":151,"commitments":152,"compensation":153,"drugs_mentioned":154},"This is a Phase II interventional study with 214 planned participants. Some participants will be randomized to receive screening MRI or no screening MRI, while others will be in single-arm groups receiving screening MRI.","completed","Screening MRI for Brain Metastases in Breast Cancer","This study is looking at whether using magnetic resonance imaging (MRI) of the brain can help find breast cancer that has spread to the brain (brain metastases) earlier. You might be able to join if you have breast cancer, including HER2-positive, triple-negative, hormone receptor-positive, or inflammatory breast cancer. Researchers want to see if screening MRIs improve your quality of life and reduce how often symptomatic brain metastases occur over about one year. The study is a Phase II trial, meaning it's testing the safety and effectiveness of this screening method. It aims to enroll 214 participants.","Your neurologic quality of life will be measured at 12 months, and the incidence of brain metastases will be tracked through study completion, an average of 1 year.",96,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]