Recruiting

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

ClinicalTrials.gov IDNCT06247449

PhaseNA

Enrollment100

SponsorSunnybrook Health Sciences Centre

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this 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.

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.

Primary outcomes

Asymptomatic brain metastasis frequency among HER2+ patients (18 months)
Asymptomatic brain metastasis frequency among Triple Negative patients (18 months)

Eligibility information

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 locations

Sunnybrook Health Science Centre, Toronto, Ontario M4N 3M5 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.