Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer
Status:
Not yet recruiting
Trial end date:
2025-03-30
Target enrollment:
Participant gender:
Summary
The overall survival of patients with metastatic breast cancer has steadily improved over the
past decades, mainly due to advances in systemic treatment. Despite these advances, the
development of brain metastases remains a serious and devastating complication that decreases
quality of life and increases morbidity and mortality. The HER2CLIMB randomized study
demonstrated that adding the investigational drug tucatinib to the standard treatment
trastuzumab and capecitabine improved both progression-free survival and overall survival in
people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast
cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain
metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the
placebo group.
These results suggest that tucatinib may be a new standard treatment for HER2-positive
metastatic disease.
The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of
adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after
the end of local treatment.