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A Phase II Study of Neratinib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer

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Cynthia Ma, MD, PhD, Washington University, St. Louis, MO

The purpose of this study is to see whether neratinib is effective in treating HER2-negative metastatic tumors that have a specific type of genetic mutation (ERBB2). The first part of this study is a preliminary screening. During this part of the study, your tumor tissue will be tested to see if it has the specific mutation the researchers are looking for. If your tumor has the mutation, you will be given more information about the main research study, which is investigating the effectiveness of neratinib.

What does participation involve?

If you sign up for this study, "A Phase II Study of Neratnib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer," a research coordinator will send a consent form to you and:

• Ask you to obtain medical records from your doctor's office
• Send the records to the research team at no cost to you
• Evaluate your overall health based on medical records provided by your doctor's office. 

Based on this information, the research coordinator will determine if you are eligible to have your tumor tissue (either from a new biopsy or previous biopsies) tested for the HER2.

It will take 3-4 weeks for you and your research study doctor to learn whether your tumor has the specific HER2 mutation the researchers are studying. If it does, your research study doctor will give you more information about the research study so that you can decide if you want to enroll. 

If the tumor does not have this HER2 mutation, you will not be eligible for the main research study. However, information about your medical history and tumor characteristics as well as any samples collected up to this point might still be analyzed as part of this study.

Multiple sites in the U.S.