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

NCT06247449 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-18

No results posted yet for this study

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. 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.

Conditions

Interventions

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

BEHAVIORAL

Testing Morbidities Index

Questionnaire regarding the participant's perception of brain imaging.

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • Trillium Health Partners

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Katarzyna Jerzak, MD, M.Sc · Sunnybrook Health Science Centre

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2027-06-01
Completion
2028-06-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247449 on ClinicalTrials.gov