[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563064":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":46,"collaborators":48,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":85,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Imperial College London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DE-iPTV radiotherapy","EXPERIMENTAL","Patients will undergo a radiotherapy planning scan, and an upto date MRI brain with contrast. Patients will receive 5 fractions of DE-iPTV radiotherapy over 1 week.",[13],"Radiation: DE-iPTV",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","DE-iPTV","Dose-escalated VMAT-based radiotherapy, as previously described in our planning study",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lillie Pakzad-Shahabi, BSc MSc","CONTACT","02033118427","beat-breast@imperial.ac.uk",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Matt Williams, FRCR PhD","matthew.williams@imperial.ac.uk",[31],{"facility":5,"status":20,"city":32,"state":20,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"London","SW7 2AZ","United Kingdom","UK",{"type":37,"coordinates":38},"Point",[39,40],-0.12574,51.50853,{"lat":40,"lon":39},[43,45],{"name":44,"role":24,"phone":20,"phoneExt":20,"email":26},"Lillie Pakzad Shahabi, BSc MSc",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[49,51,53,56,58],{"name":50,"class":6},"University of Leicester",{"name":52,"class":6},"Centro Nacional de Investigaciones Oncologicas CARLOS III",{"name":54,"class":55},"East and North Hertfordshire NHS Trust","OTHER_GOV",{"name":57,"class":6},"Norfolk and Norwich University Hospitals NHS Foundation Trust",{"name":59,"class":6},"Imperial College Healthcare NHS Trust","100563064","beat-breast-trial-of-de-iptv-in-patients-with-primary-breast-cancer-with-brain-metastases-who-are-not-suitable-for-stereotactic-radiotherapy-100563064",false,"NCT06611306","BEAT-Breast: Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.","BEAT-Breast - Improving Outcomes for Breast Cancer Patients With Brain Metastases: a Pilot Nonrandomised Single Arm Phase 2 Clinical Trial in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy","BEAT-Breast","Inclusion Criteria\n\n1. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n2. Adult (aged 16+) patients, resident in the United Kingdom.\n3. Histologically confirmed primary breast cancer with brain metastases on MRI imaging\n4. The treating oncologist considers whole-brain radiotherapy to be the most suitable treatment outside of the trial.\n5. Eastern Cooperative Oncology Group Performance status 0, 1 or 2\n6. Able to respond to question about their quality of life, symptoms, and side effects remotely (via telephone assessments\n7. Life expectancy from extra-cranial disease \\>3 months\n\nExclusion Criteria\n\n1. Leptomeningeal disease\n2. \"Miliary\" pattern of metastases: patients with over 15 metastases are excluded (clinician-based assessment)\n3. Cystic metastases\n4. Previous whole or partial brain radiotherapy (previous surgery or SRS is acceptable)\n5. Plan for hippocampal-sparing whole brain radiotherapy.\n6. Unable to give informed consent.\n7. Prognosis less than 3 months\n8. Pregnant or nursing women\n9. Unable to complete a brain MRI and\u002For known allergy to gadolinium.","ALL","16 Years","100 Years",{"count":72,"type":73},42,"ESTIMATED","INTERVENTIONAL",[76],"NA","The aim of this study is to demonstrate if it is possible to delivering a novel and modern radiotherapy approach (Dose Escalated internal PTV (DE-iPTV)) and to collect health related quality of life in patients whose breast cancer has spread to the brain (brain metastases) at 8 weeks post enrolling into the study.\n\nThe main questions that have been set out to to answer are:\n\n* Is it possible to deliver the novel radiotherapy approach, DE-iPTV?\n* Is it possible to measure health -related quality of life?\n* What impact does the novel radiotherapy approach have on: patient's quality of life, control of the brain metastasis (control of the lesion) and steroid use?\n\nParticipants will:\n\n* Receive 5 doses of radiotherapy\n* Complete weekly quality of life (EQ-5D) assessments and medication (steroid) diaries (via telephone\u002F postal) until 12 weeks post enrolment\n* Be reviewed in clinic with up-to-date MRI scans at 8, 12 and 24 weeks post-enrolment\n* Complete a more detailed HRQoL panel of assessments will be assessed at baseline, 8 weeks, 12 weeks and 24 weeks post enrolment.",[79,80],"Brain Metastases, Adult","Breast Cancer",[82,83,84],"Radiotherapy","Brain metastases","Metastatic Breast Cancer","NOT_YET_RECRUITING","2024-10-10",{"date":88,"type":89},"2024-10-15","ACTUAL",{"date":91,"type":73},"2025-01-06",{"date":93,"type":73},"2026-12",{"name":5,"class":6},1]