Screening for brain metastases in patients with advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-centre, prospective study aims to evaluate the occurrence of asymptomatic brain metastases in patients diagnosed with stage II or III Triple Negative or HER2 positive breast cancer. Participants will undergo brain imaging, provide a blood sample for circulating tumor DNA analysis, and complete the Testing Morbidities Index to assess their experiences with the screening process. The study seeks to identify the proportion of patients with asymptomatic brain metastases and explore associated clinical and tissue-based biomarkers. All procedures must occur within one year of the initial cancer diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sunnybrook Health Science Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Katarzyna Jerzak, MD, M.Sc — Sunnybrook Health Sciences Centre
• Study coordinator: Katarzyna Jerzak, MD, M.Sc
• Email: katarzyna.jerzak@sunnybrook.ca
• Phone: 416-480-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.