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

Sunnybrook Health Sciences Centre

Status: Enrolling

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06247449

SUN#5967

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18.
2. Triple Negative OR HER2+ breast cancer (as per 2018 ASCO/CAP guidelines).
3. Stage II 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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Screening MRI

Experimental group

Description:

One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)

Treatment:

Diagnostic Test: Analysis of circulating tumor DNA

Behavioral: Testing Morbidities Index

Diagnostic Test: Brain imaging