MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC

Please see trial details below.

Inclusion criteria

• Age ≥18
• Triple negative or HER2+ breast cancer (ASCO/CAP guidelines 2018)*
• MBC, as defined as distant disease outside of the breast and local/regional lymph nodes. Physicians' clinical judgment will be used to determine the possible need for biopsy in confirming a MBC diagnosis. However, biopsy of a metastatic site is not required for pathologic confirmation of stage IV disease.
• Diagnosis of metastatic disease within 12 weeks prior to study enrollment.
• 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.

• This will generally be based on the primary cancer but in the event that a metastatic site is biopsied eligibility will be based on the ER, PR and HER2 profile of the metastasis.

Exclusion criteria

• Inability to participate in an MRI screening program as determined by the patient and/or physician. This may be on the basis of severe claustrophobia, performance status that limits additional testing, or a metal foreign body that would prevent MRI imaging.
• Inability to provide informed consent. Notably participants who require translators are allowed to enroll.
• Creatinine clearance <30 mL/min using the Cockcroft-Gault equation.
• Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm).
• ECOG Performance status >2.
• Pregnancy.
• Grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).