Trial details
Routine MRI screening versus symptom-directed screening for brain metastases among patients with triple negative and HER2+ metastatic breast cancer (MBC): A single-centre randomized phase II pilot study
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: BrM Screening
Official title: Routine MRI screening versus symptom-directed screening for brain metastases among patients with triple negative and HER2+ metastatic breast cancer (MBC): A single-centre randomized phase II pilot study
Principal Investigator: Dr. Katarzyna Jerzak
Cancer type: Breast
Cancer location: Breast
Disease stage: Advanced Cancer
Trial phase: Phase 2
Intervention: Radiology: MRI
Registration #:
Contact name: Tammy Taite
Contact phone: (416) 480-5000 x7934
Trial description:
The purpose of this study is to look at the effectiveness of a screening MRI in patients with metastatic breast cancer (MBC). Patients with HER2+ and triple negative MBC who meet other certain criteria may be able to participate. There will be two groups of patients participating in this study; one group will receive a screening MRI while the other group will receive a symptom-directed questionnaire (the standard-of-care). Patients participating will know which group they are assigned to (but will be randomly allocated to one group or the other).
Inclusion Criteria: • Age 18+ • MBC as defined as distant disease outside of the breast and local/regional lymph nodes • either triple negative tumor histology [0% estrogen receptor (ER) and 0% progesterone receptor (PR) on IHC and HER2 negative (0 on IHC, 1+ on IHC, or 2+ IHC and negative FISH)] or HER2+ status [3+IHC, or 2+IHC and positive FISH] irrespective of ER/PR expression • no symptoms of BrM or known asymptomatic BrM at study entry • 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. Exclusion Criteria: • Inability to participate in an MRI screening program as determined by the patient and/or physician • inability to provide informed consent (translators will be made available if there is a language barrier) 3) creatinine clearance <30 mL/min • established need for brain imaging apart from the breast cancer diagnosis • ECOG performance status ≥2 • pregnancy • grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).
