HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (trial in progress)

Objective Despite advances in 1L SOC (trastuzumab+pertuzumab+taxane) for patients, most HER2+ metastatic breast cancer (MBC) progresses during maintenance therapy (trastuzumab+pertuzumab). Tucatinib is a TKI approved in combination with trastuzumab and capecitabine for adults with HER2+ MBC with/without brain metastases (BMs). In HER2CLIMB, tucatinib, trastuzumab, and capecitabine significantly prolonged PFS and OS in patients with HER2+ MBC and was well tolerated. The risk of disease progression or death in patients with untreated and/or active BMs was also reduced. HER2CLIMB-05 investigates whether adding tucatinib to 1L SOC as maintenance therapy will extend PFS while maintaining quality of life (QOL).