T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
Objective
Primary Objective To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.
Secondary Objectives To evaluate whether treatment with tacatibib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: Overall survival (OS) Breast cancer free survival (DRFS) Disease-free survival (DFS) Brain metastases-free survival (BMFS)