MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are: 1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain? 2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis? 3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis? Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18.

• Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).

• Stage II 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.

Locations
Other Locations
Canada
Sunnybrook Health Science Centre
RECRUITING
Toronto
Contact Information
Primary
Katarzyna Jerzak, MD, M.Sc
katarzyna.jerzak@sunnybrook.ca
416-480-6100
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 100
Treatments
Experimental: Screening MRI
One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Princess Margaret Hospital, Canada, MOUNT SINAI HOSPITAL, Trillium Health Partners

This content was sourced from clinicaltrials.gov

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