Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06247449

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain imaging

Analysis of circulating tumor DNA

Testing Morbidities Index

Study Details

Brief 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

Breast Cancer

Study ID

NCT06247449

Start date

Nov 29, 2023

Status verified date

Nov, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Screening MRI

One-time contrast-enhanced brain magnetic resonance imaging (MRI), blood draw for circulating tumor DNA and assessment via the Testing Morbidity Index (TMI)

Interventions

Brain imaging

Contrast-enahanced Brain Magnetic Resonance Imaging (MRI)

Analysis of circulating tumor DNA

Blood draw for analysis of circulating tumor DNA

Testing Morbidities Index

Questionnaire regarding the participant's perception of brain imaging.

Primary outcome measure

  • Asymptomatic brain metastasis frequency among HER2+ patients [ Time Frame: 18 months ]
  • Asymptomatic brain metastasis frequency among Triple Negative patients [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Katarzyna Jerzak, MD, M.Sc

416-480-6100katarzyna.jerzak@sunnybrook.ca

Locations

Sunnybrook Health Science Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Katarzyna Jerzak, MD M.Sc

416-480-6100katarzyna.jerzak@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 18, 2025

Last verified

Nov, 2025

Keywords

  • HER2
  • Triple Negative
  • Brain Metastasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-12-18.