Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06247449

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Katarzyna Jerzak, MD M.Sc

CONTACT

[email protected]

416-480-6100 ext. 5248

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

brain imaging

Diagnostic Test

Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)

Analysis of circulating tumor DNA

Diagnostic Test

Blood draw for analysis of circulating tumor DNA

Testing Morbidities Index

Behavioral

Questionnaire regarding the participant's perception of brain imaging.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Acceptability of brain imaging to patients

    Time frame: 18 months

    Proportion of patients who are approached about the study who agree to enroll

  2. Patients' acceptability of the brain magnetic resonance imaging

    Time frame: 18 months

    Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)

  3. Proportion of patients who have subsequent brain magnetic resonance imaging

    Time frame: 36 months

    Annual chart review to determine the frequency of patients who have subsequent brain imaging performed after the first trial magnetic resonance imaging

Other outcomes

  1. Exploratory biomarkers

    Time frame: 36 months.

    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.

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

    Time frame: 36 months.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katarzyna Jerzak, MD, M.Sc

CONTACT

[email protected]

416-480-6100 ext. 5248

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • MOUNT SINAI HOSPITAL
  • Princess Margaret Hospital, Canada
  • Trillium Health Partners

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 7, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.