Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-155
Prinicipal Investigator
Truica, Cristina
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
A011801
Title
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)
Applicable Disease Sites
Melanoma, Skin
Status
Open
Participating Institutions
Hershey Medical Center