HER2CLIMB — Tucatinib plus Trastuzumab and Capecitabine in Previously Treated HER2-Positive Metastatic Breast Cancer

Phase 2 · 2020 · Breast Cancer

Design

Randomized tucatinib versus placebo added to trastuzumab + capecitabine, including patients with brain metastases.

Population

HER2-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and T-DM1, including active/stable brain metastases.

Primary Endpoint

progression-free survival (PFS)

Key Result

Tucatinib improved PFS (HR 0.54) and overall survival (HR 0.66), with benefit in patients with brain metastases (intracranial PFS HR 0.32).

Guideline Impact

Third-line+ HER2-positive metastatic breast cancer with/without brain metastases