Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
Study NCT ID:
NCT06728150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissues form past breast cancer or brain metastases tissues and blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2024-11-13', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of screen-detected asymptomatic brain metastasis.', 'timeFrame': '12 months', 'description': 'CT scan of the brain used to determine evidence of new metastases.'}], 'secondaryOutcomes': [{'measure': 'Incidence of symptomatic brain metastases', 'timeFrame': 'Though to study completion, an average of 1 year', 'description': 'CT scans of the brain'}, {'measure': 'Progression free survival', 'timeFrame': 'Though to study completion, an average of 1 year', 'description': 'Time form entry into the study to brain metastases development'}, {'measure': 'Overall survival', 'timeFrame': 'Though to study completion, an average of 1 year', 'description': 'Time form entry into the study to death'}, {'measure': 'Number of surgical resections', 'timeFrame': 'Though to study completion, an average of 1 year', 'description': 'The number of patients who develop brain metastases having surgery'}, {'measure': 'Rate of stereotactic radiotherapy', 'timeFrame': 'Though to study completion, an average of 1 year', 'description': 'The number of patients having stereotactic radiotherapy assesses using medical records'}, {'measure': 'Evaluation of the role of early treatment on intracranial disease control', 'timeFrame': 'Though to study completion, an average of 1 year', 'description': 'Time form initial surgical or radiotherapy or observation to progression of disease'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer brain metastases'], 'conditions': ['Breast Cancer Metastatic', 'Brain Metastasases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging.\n\nIn patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness.\n\nIn current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and/or a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered.\n\nWhen initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain.\n\nParticipants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records.\n\nSome participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients.\n\nIf the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue).\n\nThe information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of metastatic breast cancer.', 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic breast cancer with visceral, nodal or bone metastasis\n* Human epidermal growth factor type2 (HER2-positive disease)\n* Triple negative breast cancer (TNBC) with metastatic disease\n* Oestrogen Receptor Positive disease (ER-positive disease) after second-line therapy and cyclin dependent kinase 4/6 inhibitors (CDK4/6 inhibitors), plus more than two sites of bone metastasis or visceral metastasis\n* Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with brain MRI confirmation) • Medicare Eligible\n\nExclusion Criteria:\n\n* Symptomatic brain metastasis\n* Inability to provide consent\n* Inadequate organ function\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT06728150', 'acronym': 'STORM', 'briefTitle': 'Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'Project 331/22'}}, 'armsInterventionsModule': {'interventions': [{'name': 'computerized tomography', 'type': 'RADIATION', 'description': 'The patients will have 3 monthly CT scans of the brain for 2 years and 6 monthly CT scans for 2 years for total of 4 years.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Mahesh Iddawela, MBBS FRACP PhD', 'role': 'CONTACT', 'email': 'mahesh.iddawela@monash.edu', 'phone': '61351738000'}, {'name': 'Neethu Namia, BSc', 'role': 'CONTACT', 'email': 'neeth.namia@alfred.org.au', 'phone': '61 3 9076 9625'}], 'overallOfficials': [{'name': 'Mahesh Iddawela, MBBS FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor and Medical Oncologist'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After 4 years', 'ipdSharing': 'YES', 'description': 'The details of the protocol, patient information sheet, de-identified data and analysis', 'accessCriteria': 'With ethics approval from The Alfred ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Alfred', 'class': 'OTHER'}, {'name': 'Breast Cancer Trials, Australia and New Zealand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mahesh Iddawela', 'investigatorAffiliation': 'Monash University'}}}}