An interventional study of MRI screening in Breast Neoplasm, Brain Metastases and Triple Negative Breast Cancer, sponsored by Sunnybrook Health Sciences Centre. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Screening
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre. They will be randomized to undergo either routine MRI screening of their brain every 4 months for 1 year or standard-of-care (MRI only if symptoms of brain metastases develop). Patients will complete questionnaires about quality of life and cancer-related anxiety throughout the study. To determine why some cancers spread to the brain and others do not, blood samples will be collected to analyze the genetic makeup of patients' breast cancers. Finally, a novel MRI imaging technique that detects abnormal metabolism in the brain will be used to help detect brain metastases even earlier than the standard MRI.
If results are promising, we will conduct a large multi-centre randomized trial to determine whether screening for brain metastases can help them live longer with improved quality of life.
Please see trial details below.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate.
Exclusion Criteria:
Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months.
Diagnostic Test: MRI screening
Imaging of the brain will take place only if patients develop symptoms that are suggestive of brain metastases (e.g. headaches, vision changes, gait instability).
A standard contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain will be performed at baseline, 4 months, 8 months and 12 months.
Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
This outcome is intended to assess the feasibility of a future large, multi-center randomized trial.
Time frame: 15 months.
Proportion of patients in the control arm who undergo imaging of the brain with CT or MRI.
This outcome is intended to assess the incidence of screening "contamination" in the control arm of the study.
Time frame: 12 months
Incidence of symptomatic brain metastases.
To be assessed in both study arms.
Time frame: Baseline, 4-, 8- and 12-months.
Number of interventions used to treat brain metastases.
To be assessed in both study arms.
Time frame: 15 months
Size and location of BrM per patient.
To be assessed in both study arms.
Time frame: At the time of diagnosis of brain metastases (from enrollment to 15 months)
Neurologic-specific quality-of-life (The Functional Assessment of Cancer Therapy-Brain; FACT-BR version 4 tool).
To be assessed in both study arms; 37 questions are rated from a scale of 0 to 4 (total score 0 to 185 where a lower score indicates better quality-of-life)
Time frame: Baseline, 6 months and 15 months.
Overall quality-of-life (EORTC core quality of life questionnaire; EORTC QLQ-C30 version 3 tool).
To be assessed in both study arms; ; 30 questions are rated from a scale of 1 to 4 (total score 30 to 120 where a lower score indicates better quality-of-life)
Time frame: Baseline, 6 months and 15 months.
Cancer-related anxiety (NCI PRO-CTCAE for anxiety).
To be assessed in both study arms.
Time frame: Baseline, 6 months and 15 months.
Time to death due to any cause.
To be assessed in both study arms.
Time frame: 15 months.
Time to death due to neurologic progression.
To be assessed in both study arms.
Time frame: 15 months.
Proportion of patients with changes in CEST imaging that are suggestive of brain metastases prior to confirmation on contrast-enhanced MRI imaging.
Exploratory outcome.
Time frame: Baseline, 4-, 8- and 12-months.
Plan to share: Yes — IPD which does not include any patient identifiers will be considered but will require Research Ethics Board approval and appropriate legal contracts between collaborating institutions to ensure protection of patient data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The study documents (protocol, statistical analysis plan and informed consent form) can be made available at any time. Data may be available after study completion.
Access criteria: Research Ethics Board approval and appropriate legal contracts between collaborating institutions will be required prior to data-sharing to ensure protection of patient data.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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