A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination with Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

Protocol No
SEAGEN-SGNTUC-028-HER2CLIMB-05
Principal Investigator
Sailaja Kamaraju
Phase
III
Summary
The purpose of this project is to test if your cancer cells make a marker called HER2. The drug in this study, Tucatinib, is designed to find and stick to breast cancer cells that make HER2. The name of the clinical study is SGNTUC-028. It will test a drug called Tucatinib. The Food and Drug Administration (FDA) has approved Tucatinib for sale in the US. It is approved for adults with HER2 positive breast cancer that is advanced or has spread through the body and cannot be removed with surgery. This includes patients whose cancer has spread to their brain.Tucatinib is approved for use with 2 anti-cancer drugs, Trastuzumab and Capecitabine. The brand name for Tucatinib is TUKYSA®. Tucatinib has not been approved for other diseases. Tucatinib has not been approved for use with Trastuzumab and Pertuzumab, the drugs being tested in this study. This makes it investigational in this study. In the study, Tucatinib is being used with two other drugs called Trastuzumab and Pertuzumab. Trastuzumab and Pertuzumab are used to treat HER2 positive breast cancer. These are drugs you may get for your cancer as part of your regular medical care.
Description
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
Sub Category