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

Phase 3 Active not recruiting 1056 enrolled Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) · collab Seagen Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib is in a class of medications called kinase inhibitors. It blocks HER2, which may help keep cancer cells from growing and may kill them. Giving T-DM1 in combination with tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

Timeline

Start: 2021-03-02
Primary completion: 2028-01-31
Completion: 2035-05-31

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tucatinib	Small molecule	—	Oral
Background	Trastuzumab emtansine	Other / unclassified	—	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications