Breast CancerNCT06247449
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer
A study testing Brain imaging, Analysis of circulating tumor DNA and Testing Morbidities Index in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage IIb or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Brain imaging, Analysis of circulating tumor DNA and Testing Morbidities Index
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 29 Nov 2023to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18.
- Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
- Stage IIb or III disease.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
- Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
- Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Katarzyna Jerzak, MD M.Sc, 416-480-6100 ext. 5248, katarzyna.jerzak@sunnybrook.ca
About this study
Official title: MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage IIb or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:
- 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?
- How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis?
- 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.
- Conditions
- Breast Cancer
- Being tested
- Brain imaging, Analysis of circulating tumor DNA, Testing Morbidities Index
- Keywords
- HER2, Triple Negative, Brain Metastasis
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain imagingDiagnostic test
Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)
Analysis of circulating tumor DNADiagnostic test
Blood draw for analysis of circulating tumor DNA
Testing Morbidities IndexBehavioural
Questionnaire regarding the participant's perception of brain imaging.
| Study group | Role | What they receive |
|---|---|---|
| Screening MRI | Experimental | One-time contrast-enhanced brain magnetic resonance imaging (MRI), blood draw for circulating tumor DNA and assessment via the Testing Morbidity Index (TMI) Receives: Diagnostic Test: Brain imaging; Diagnostic Test: Analysis of circulating tumor DNA; Behavioral: Testing Morbidities Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic brain metastasis frequency among HER2+ patients
Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis
Measured: 18 months
Asymptomatic brain metastasis frequency among Triple Negative patients
Proportion of eligible patients with Stage IIb or III Triple Negative breast cancer who have asymptomatic brain metastasis
Measured: 18 months
Secondary outcomes (3)
Acceptability of brain imaging to patients
Proportion of patients who are approached about the study who agree to enroll
Measured: 18 months
Patients' acceptability of the brain magnetic resonance imaging
Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)
Measured: 18 months
Proportion of patients who have subsequent brain magnetic resonance imaging
Annual chart review to determine the frequency of patients who have subsequent brain imaging performed after the first trial magnetic resonance imaging
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start29 Nov 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients (30 with TN and 30 with HER2+ breast cancer) will be recruited initially as part of a 2-stage design. If at least 1 out of 30 recruited patients is diagnosed with a BrM (3.3% incidence), then an additional 70 patients will be recruited to characterize the risk of BrM among 100 patients in the relevant subgroup (TN and/or HER2+).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, MOUNT SINAI HOSPITAL, Trillium Health Partners
- Responsible party
- Sponsor
- Investigators
- Katarzyna Jerzak, MD, M.Sc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247449
- Sponsor's protocol ID
- SUN#5967
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06247449
- Acronym / sponsor ID
- SUN#5967
- Conditions
- Breast Cancer
- Keywords
- HER2, Triple Negative, Brain Metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, MOUNT SINAI HOSPITAL, Trillium Health Partners
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage IIb or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:
- 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?
- How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis?
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients (30 with TN and 30 with HER2+ breast cancer) will be recruited initially as part of a 2-stage design. If at least 1 out of 30 recruited patients is diagnosed with a BrM (3.3% incidence), then an additional 70 patients will be recruited to characterize the risk of BrM among 100 patients in the relevant subgroup (TN and/or HER2+).
| Arm | Type | Receives |
|---|---|---|
| Screening MRI | Experimental | Diagnostic Test: Brain imaging, Diagnostic Test: Analysis of circulating tumor DNA, Behavioral: Testing Morbidities IndexOne-time contrast-enhanced brain magnetic resonance imaging (MRI), blood draw for circulating tumor DNA and assessment via the Testing Morbidity Index (TMI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18.
- Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
- Stage IIb or III disease.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
- Pregnant women are not permitted to participate given that the safety of IV contrast is unknown in this population.
- Patients with central nervous system symptoms that are concerning for brain metastases that would otherwise be referred for brain imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain imagingContrast-enahanced Brain Magnetic Resonance Imaging (MRI) | Diagnostic test | Screening MRI |
| Analysis of circulating tumor DNABlood draw for analysis of circulating tumor DNA | Diagnostic test | Screening MRI |
| Testing Morbidities IndexQuestionnaire regarding the participant's perception of brain imaging. | Behavioural | Screening MRI |
Primary outcome
Asymptomatic brain metastasis frequency among HER2+ patients
Time frame: 18 months
Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis
Asymptomatic brain metastasis frequency among Triple Negative patients
Time frame: 18 months
Proportion of eligible patients with Stage IIb or III Triple Negative breast cancer who have asymptomatic brain metastasis
3 secondary outcomes
Acceptability of brain imaging to patients
Time frame: 18 months
Patients' acceptability of the brain magnetic resonance imaging
Time frame: 18 months
Proportion of patients who have subsequent brain magnetic resonance imaging
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarzyna Jerzak, MD, M.Sc principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain imaging, Analysis of circulating tumor DNA and Testing Morbidities Index in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Jerzak, MD, M.Sc (416-480-6100 ext. 5248, katarzyna.jerzak@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymptomatic brain metastasis frequency among HER2+ patients (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.