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

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Testing Morbidities Index; Diagnostic test: Brain imaging; Diagnostic test: Analysis of circulating tumor DNA

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katarzyna Jerzak, MD, M.Sc; Phone Number: 5248 416-480-6100; Email: katarzyna.jerzak@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Science Centre
      • Contact: Katarzyna Jerzak, MD M.Sc; Phone Number: 5248 416-480-6100; Email: katarzyna.jerzak@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18.
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:

1. Creatinine clearance <30 mL/min using the Cockcroft-Gault equation (in accordance with the product monograph for Gadavist IV contrast.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: Testing Morbidities Index; Questionnaire regarding the participant's perception of brain imaging.; Diagnostic test: Brain imaging; Contrast-enahanced Brain Magnetic Resonance Imaging (MRI); Diagnostic test: Analysis of circulating tumor DNA; Blood draw for analysis of circulating tumor DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of brain imaging to patients	Proportion of patients who are approached about the study who agree to enroll	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)	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	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory biomarkers	Evaluate a possible correlation between the presence of circulating tumor DNA in the blood of patients at the time of study enrollment and future development of brain metastases when the study has been completed.	36 months.
Correlation between circulating tumor DNA in the blood at enrollment and incidence of brain metastases at the end of the study	Evaluate a possible correlation between the presence of circulating tumor DNA in the blood of patients at the time of study enrollment and the incidence of brain metastases when the study has been completed.	36 months.

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: MOUNT SINAI HOSPITAL; Princess Margaret Hospital, Canada; Trillium Health Partners
• Investigators: Principal Investigator: Katarzyna Jerzak, MD, M.Sc, Sunnybrook Health Science Centre

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: HER2; Triple Negative; Brain Metastasis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Central Nervous System Neoplasms; Skin and Connective Tissue Diseases; Breast Neoplasms; Brain Neoplasms; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Neurological; Neuroimaging
• Other Study ID Numbers: SUN#5967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No