Overview

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

Status:
Recruiting

Trial end date:
2023-10-01

Target enrollment:

Participant gender:

Summary

This is a single arm, open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of HER2+ breast cancer brain metastases (BCBM). A total of 33 patients with untreated or previously treated and progressing HER2+ BCBM not requiring urgent central nervous system (CNS)-directed therapy will be enrolled. The study will determine the recommended dose of tucatinib in this combination and assess the efficacy of this combination in controlling CNS disease in patients with HER2+ BCBM.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Reva Basho

Collaborators:

Merck Sharp & Dohme Corp.
Seagen Inc.
Seattle Genetics, Inc.

Treatments:

Pembrolizumab
Trastuzumab
Tucatinib