Screening for brain metastases in patients with advanced breast cancer
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study
NA · Sunnybrook Health Sciences Centre · NCT06247449
This study is testing how common hidden brain metastases are in patients with advanced breast cancer and looking at their experiences during the screening process.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06247449 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stage II or III Triple Negative or HER2 positive breast cancer.
Not a fit: Patients with central nervous system symptoms indicative of brain metastases or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of brain metastases in breast cancer patients.
How similar studies have performed: Other studies have shown promise in screening for brain metastases in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- Sunnybrook Health Science Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Katarzyna Jerzak, MD, M.Sc — Sunnybrook Health Science Centre
- Study coordinator: Katarzyna Jerzak, MD, M.Sc
- Email: katarzyna.jerzak@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, HER2, Triple Negative, Brain Metastasis