1. Any indication for immediate CNS-directed therapy.

2. History of generalized or complex partial seizures.

3. Any other manifestation of neurologic progression that in the opinion of the treating physician is due to brain metastases.

4. Leptomeningeal disease.

5. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.

6. Prior therapy with tucatinib.

7. Active autoimmune disease that has required systemic treatment in excess of prednisone 10mg daily or equivalent in the past 2 years.

TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases

What this study is about