MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

NCT06247449 | Recruiting

• 1 other identifier: SUN#5967
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.How do patients feel about undergoing brain imaging to screen for asymptomatic brain metastasis?
3. 3.What clinical as well as liquid and tissue-based biomarkers are associated with asymptomatic detection of brain metastasis?

Conditions

Breast Cancer

Keywords

HER2; Triple Negative; Brain Metastasis

Outcome Measures

Primary Outcomes (2)

• Asymptomatic brain metastasis frequency among HER2+ patients

  Proportion of eligible patients with Stage IIb or III HER2+ breast cancer who have asymptomatic brain metastasis

  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

  18 months

Secondary Outcomes (3)

• Acceptability of brain imaging to patients

  18 months

• Patients' acceptability of the brain magnetic resonance imaging

  18 months

• Proportion of patients who have subsequent brain magnetic resonance imaging

  36 months

Other Outcomes (2)

• Exploratory biomarkers

  36 months.

• Correlation between circulating tumor DNA in the blood at enrollment and incidence of brain metastases at the end of the study

  36 months.

Study Arms (1)

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)

Diagnostic Test: Brain imaging; Diagnostic Test: Analysis of circulating tumor DNA; Behavioral: Testing Morbidities Index

Interventions

Brain imaging DIAGNOSTIC_TEST

Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)

Screening MRI

Analysis of circulating tumor DNA DIAGNOSTIC_TEST

Blood draw for analysis of circulating tumor DNA

Screening MRI

Testing Morbidities Index BEHAVIORAL

Questionnaire regarding the participant's perception of brain imaging.

Screening MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Princess Margaret Hospital, Canada: collaborator
• MOUNT SINAI HOSPITAL: collaborator
• Trillium Health Partners: collaborator

Study Sites (1)

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Katarzyna Jerzak, MD, M.Sc

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Jerzak, MD, M.Sc

CONTACT

416-480-6100; katarzyna.jerzak@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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+).

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 7, 2024
• Study Start: November 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)