Nctid:
NCT06611306
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001943", "term"=>"Breast Neoplasms"}, {"id"=>"D000009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D000016609", "term"=>"Neoplasms, Second Primary"}, {"id"=>"D000001932", "term"=>"Brain Neoplasms"}], "ancestors"=>[{"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000001941", "term"=>"Breast Diseases"}, {"id"=>"D000012871", "term"=>"Skin Diseases"}, {"id"=>"D000009385", "term"=>"Neoplastic Processes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000016543", "term"=>"Central Nervous System Neoplasms"}, {"id"=>"D000009423", "term"=>"Nervous System Neoplasms"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Metastases", "relevance"=>"HIGH"}, {"id"=>"M18989", "name"=>"Neoplasms, Second Primary", "asFound"=>"Metastases", "relevance"=>"HIGH"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "asFound"=>"Brain Metastases", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M12367", "name"=>"Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M18937", "name"=>"Central Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"Non-randomised interventional multi-centre feasibility trial in patients with brain metastases from breast cancer receiving dose escalated internal PTV (DE-iPTV) radiotherapy"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>42}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Changes in blood-based biomarkers", "timeFrame"=>"8 weeks", "description"=>"Change between baseline and week 8 levels of Circulating Tumour DNA (ctDNA) and S100"}, {"measure"=>"Imaging Changes", "timeFrame"=>"Up to 6 months post enrolment", "description"=>"MRI-based response (as per RANO-BM and serial volumetric measurements)"}, {"measure"=>"Radiation Necrosis", "timeFrame"=>"Up to 6 months post enrolment", "description"=>"Radiation necrosis based on radiologist report"}], "primaryOutcomes"=>[{"measure"=>"Feasibility of delivering DE-iPTV and measuring health related quality of life questionnaire (HRQoL) in patients with brain metastases from breast cancer to whom their treating clinician would normally offer whole brain radiotherapy", "timeFrame"=>"8 weeks post-enrolment", "description"=>"Completion of radiotherapy and completion of EuroQol- 5 Dimension (EQ-5D-5L) HRQoL questionnaire)"}], "secondaryOutcomes"=>[{"measure"=>"Lesional Response", "timeFrame"=>"8 weeks", "description"=>"Lesional response and intracranial progression measured using RANO-BM criteria"}, {"measure"=>"Intracranial progression", "timeFrame"=>"3 months", "description"=>"Intracranial progression based on RANO-BM"}, {"measure"=>"Intracranial progression", "timeFrame"=>"6 months", "description"=>"Intracranial progression based on RANO-BM"}, {"measure"=>"Treatments", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Use of further brain-directed therapies (reported by clinician)"}, {"measure"=>"Central Nervous System (CNS) Failures", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Time to CNS failure (either lesional progression or developing a new lesion as per RANO-BM)"}, {"measure"=>"Neurological toxicities", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Acute and late neurological/ CNS toxicity as assessed using CTCAE v5"}, {"measure"=>"Health Related Quality of Life", "timeFrame"=>"Within 6 months of enrolment", "description"=>"HRQoL over time (participants reported outcomes for descriptive analysis)"}, {"measure"=>"Time to deterioration in quality of life", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Time to deterioration in HRQoL - measured as time to first time there is a minimum clinically significant change in EQ-5D-5L"}, {"measure"=>"Symptom Burden", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Symptom burden assessed by collection of clinician-recorded toxicities"}, {"measure"=>"Steroid usage", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Use of corticosteroids over time, assessed through clinician reports and patient diaries"}, {"measure"=>"Quality-Adjusted Life Year", "timeFrame"=>"Within 6 months of enrolment", "description"=>"Quality-Adjusted Life Year"}, {"measure"=>"Overall survival", "timeFrame"=>"End of study", "description"=>"Overall survival"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Radiotherapy", "Brain metastases", "Metastatic Breast Cancer"], "conditions"=>["Brain Metastases, Adult", "Breast Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"35182688", "type"=>"BACKGROUND", "citation"=>"Chen J, Sinclair G, Rozati H, Hill L, Pakzad-Shahabi L, Wang J, Calvez KL, Paddick I, Williams M. Improving on whole-brain radiotherapy in patients with large brain metastases: A planning study to support the AROMA clinical trial. Radiother Oncol. 2022 May;170:176-183. doi: 10.1016/j.radonc.2022.02.011. Epub 2022 Feb 17."}], "seeAlsoLinks"=>[{"url"=>"https://www.computationaloncology.net/aroma", "label"=>"Related Info"}]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study is to demonstrate if it is possible to delivering our 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 we 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 (lesional control) 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/ 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.", "detailedDescription"=>"Brain metastases from breast cancer are a common, and devastating, complication with survival times of 3 - 5 months from diagnosis.\n\nThe main treatment approaches to brain metastases are surgery, stereotactic radiosurgery (SRS), and whole brain radiotherapy. However, we know that most patients with brain metastases receive either whole-brain radiotherapy (WBRT) or no treatment, with relatively low rates of surgery and SRS. Since the commonest treatment in those who do have treatment is WBRT, we have developed an approach to improve that we think may be more effective than WBRT. We want to evaluate this approach in patients who are not suitable to receive more aggressive treatment and who would otherwise receive WBRT. Our approach involves using a modern radiotherapy planning approach, combined with careful, intra-metastasis dose escalation (Dose Escalated internal PTV (DE-iPTV)) to deliver a higher dose to tumour, while delivering less dose to the brain. The combination of less dose to normal structures and more dose to the lesion will hopefully improve Health-related Quality of Life (HRQoL).\n\nThe aim of this study is to demonstrate the feasibility of delivering complex radiotherapy, dose escalated internal PTV (DE-iPTV), and measuring quality of life at 8 weeks post-enrolment for patients with brain metastases from breast cancer who would otherwise receive WBRT. In these patients, we will complete an exploratory blood-based biomarker sample collection and analysis. Furthermore, we will use linked national cancer data to measure the number of patients currently offered WBRT, including survival costs and hospital admissions, and thus provide a baseline to estimate the impact of our novel approach."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"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/or known allergy to gadolinium."}, "identificationModule"=>{"nctId"=>"NCT06611306", "acronym"=>"BEAT-Breast", "briefTitle"=>"BEAT-Breast: A Pilot Non-randomised Single Arm Phase 2 Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy.", "organization"=>{"class"=>"OTHER", "fullName"=>"Imperial College London"}, "officialTitle"=>"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", "orgStudyIdInfo"=>{"id"=>"C/46/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"DE-iPTV radiotherapy", "description"=>"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.", "interventionNames"=>["Radiation: DE-iPTV"]}], "interventions"=>[{"name"=>"DE-iPTV", "type"=>"RADIATION", "description"=>"Dose-escalated VMAT-based radiotherapy, as previously described in our planning study", "armGroupLabels"=>["DE-iPTV radiotherapy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"SW7 2AZ", "city"=>"London", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Lillie Pakzad Shahabi, BSc MSc", "role"=>"CONTACT", "email"=>"beat-breast@imperial.ac.uk"}, {"name"=>"Matt Williams, FRCR PhD", "role"=>"CONTACT", "email"=>"matthew.williams@imperial.ac.uk", "phone"=>"02033118427"}], "facility"=>"Imperial College London", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}], "centralContacts"=>[{"name"=>"Lillie Pakzad-Shahabi, BSc MSc", "role"=>"CONTACT", "email"=>"beat-breast@imperial.ac.uk", "phone"=>"02033118427"}, {"name"=>"Matt Williams, FRCR PhD", "role"=>"CONTACT", "email"=>"matthew.williams@imperial.ac.uk", "phone"=>"02033118427"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Imperial College London", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University of Leicester", "class"=>"OTHER"}, {"name"=>"Centro Nacional de Investigaciones Oncologicas CARLOS III", "class"=>"OTHER"}, {"name"=>"East and North Hertfordshire NHS Trust", "class"=>"OTHER_GOV"}, {"name"=>"Norfolk and Norwich University Hospitals NHS Foundation Trust", "class"=>"OTHER"}, {"name"=>"Imperial College Healthcare NHS Trust", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
