HER2-Positive Breast Cancer with Brain Metastases: HCC 19-005 (TBCRC 022)

STUDY BASICS

Do you have HER2-positive breast cancer that has spread to the brain? If so, you may be eligible to participate in a research study to help find out if an investigational combination of drugs called ado-trastuzumab emtansine (also known as T-DM1 or Kadcyla®) and neratinib (also known as Nerlynx®) is safe and effective for people with HER2-positive breast cancer that has spread to the brain.

STUDY PURPOSE

Breast cancer that has spread to the brain can be difficult to treat. The purpose of this study is to help researchers find out if an investigational combination of drugs called ado-trastuzumab emtansine (also known as T-DM1 or Kadcyla®) and neratinib (also known as Nerlynx®) is a safe and effective treatment for people with HER2-positive breast cancer with brain metastases. Both medications have both been approved separately for use in people with breast cancer in other settings, but they are not specifically approved when given together for the treatment of breast cancer or breast cancer that has spread to the brain.

COULD THIS STUDY BE RIGHT FOR YOU?

• Males and females ages 18 and up
• Diagnosed with HER2-positive breast cancer that has spread to the brain

WHAT PARTICIPANTS CAN EXPECT

Participation involves an initial screening phase to find out if you are eligible for the study. If eligible, participants will be given neratinib tablets (160 mg) to take by mouth once per day and an injection of ado-trastuzumab emtansine once every 3 weeks. Tests and assessments during the study include physical exam, blood draws, electrocardiogram, echocardiogram, CT or MRI scan, and surveys.