MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer
NCT ID: NCT06247449
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-11-29
2028-06-01
Brief Summary
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1. What proportion of patients with stage IIb or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (MRI) of the brain?
2. How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis?
3. What clinical as well as liquid and tissue-based biomarkers are associated with asymptomatic detection of brain metastasis?
Participants will undergo brain imaging, provide one blood sample (for analysis of ctDNA), and complete the Testing Morbidities Index (TMI) questionnaire after imaging is done. Procedures may take place either prior to or after completion of (neo)-adjuvant systemic therapy; however, the study interventions must take place within 18 months of initial breast cancer diagnosis.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening MRI
One-time contrast-enhanced brain magnetic resonance imaging (MRI), blood draw for circulating tumor DNA and assessment via the Testing Morbidity Index (TMI)
Brain imaging
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)
Analysis of circulating tumor DNA
Blood draw for analysis of circulating tumor DNA
Testing Morbidities Index
Questionnaire regarding the participant's perception of brain imaging.
Interventions
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Brain imaging
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)
Analysis of circulating tumor DNA
Blood draw for analysis of circulating tumor DNA
Testing Morbidities Index
Questionnaire regarding the participant's perception of brain imaging.
Eligibility Criteria
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Inclusion Criteria
2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
3. Stage IIb or III disease.
4. 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.
5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
2. Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
3. Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
18 Years
ALL
No
Sponsors
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Princess Margaret Hospital, Canada
OTHER
MOUNT SINAI HOSPITAL
OTHER
Trillium Health Partners
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Katarzyna Jerzak, MD, M.Sc
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Science Centre
Locations
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Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Katarzyna Jerzak, MD M.Sc
Role: primary
Other Identifiers
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SUN#5967
Identifier Type: -
Identifier Source: org_study_id