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

CNS objective response rate (ORR)

Proportion of participants with confirmed CR or PR per RANO-BM Criteria

Time frame: From baseline until the date of first documented progression or study discontinuation. Assessed up to 2 years.

Systemic ORR

Proportion of participants with confirmed CR or PR per RECIST v.1.1

Time frame: From baseline until the date of first documented progression or study discontinuation. Assessed up to 2 years.

Progression-free survival (PFS)

From date of registration to date of first documentation of true progression or symptomatic deterioration (as defined above), or death due to any cause. Patients last known to be alive and progression free are censored at date of last assessment. PFS will be assessed in the CNS and systemically.

Time frame: From baseline to first documentation of true progression or symptomatic deterioration, or death due to any cause. Assessed up to 2 years.

Overall Survival (OS)

From date of registration to date of death due to any cause. Patient's last known to be alive are censored at date of last contact.

Time frame: From baseline until death or 3 years, whichever occurs first.