Researchers participating HCRN BRE21-516, also known as BRIDGET, had their work featured as a Trials in Progress abstract at the Society for NeuroOncology Annual Summit. The study focuses on secondary brain metastases prevention after isolated intracranial progression on trastuzumab/pertuzumab or T-DM1 in patients with advanced human epidermal growth factor receptor 2+ breast cancer with the addition of tucatinib.

BRIDGET is a single arm, phase II study of tucatinib added to TP or T-DM1 after local therapy in patients with isolated brain relapse or progression. A total of 48 patients at 9 U.S. sites through HCRN with HER2+ MBC will be enrolled after 1st or 2nd BrM relapse/progression within 8 weeks of local therapy.

In this trial patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled. Patients will receive local therapy with stereotactic radiosurgery ± surgical resection if indicated followed by enrollment. Patients will continue standard of care trastuzumab/pertuzumab or T-DM1 with the addition of tucatinib. Hormone receptor positive patients requiring endocrine therapy should continue.

Study treatment will continue until disease progression or intolerable side effects. Patients on trial with extracranial disease progression with stable intracranial disease should continue tucatinib into next line of therapy.

Investigators of this study hypothesize that adding tucatinib to TP or T-DM1 in patients with HER2+ MBC with isolated brain relapse or progression could delay or prevent the development of further intracranial lesions and improve overall survival.
The primary objective is intracranial progression free survival compared to a historical control of the HER2CLIMB trial. In these patients, median time from brain progression to second progression/death was 7.6 months with tucatinib versus 3.1 months in the control arm.

Read the full article.

Authors: Amanda Van Swearingen, Sarah Sammons, Laura Noteware, Nusayba Bagegni, Kelly Moulton, Stevie Threatt, Denise Jaggers, Shannon Shea, Eric Lipp, Erin Riley, Sin-Ho Jung, Gloria Broadwater, Masey Ross, Kimberly Strickland, Sasha Beyer, Alison Conlin, Aki Morikawa, Rashmi Murthy, and Carey Anders

Institutions: Dana Farber, Duke Cancer Institute, MD Anderson, Ohio State University Comprehensive Cancer Center, University of Michigan Health System, Providence Health System, Washington University School of Medicine.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.