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Metastatic HER2 Non-Amplified but HER2 Mutant Breast Cancer Treatment Study

Clinical Trial Title: 
A phase II study of neratinib in metastatic HER2 non-amplified but HER2 mutant breast cancer
Clinical Trial Protocol ID: 
13041901
Clinical Trial Investigator Name: 
Melody A. Cobleigh, MD
Clinical Trial Protocol Description: 

HER2 is a protein involved in normal cell growth. Some types of breast cancer test positive for overexpression HER2 and some test negative for overexpression HER2, and there are different treatments depending on whether the breast cancer is HER2 positive or negative. However, doctors are discovering that there is a third group of people—people who have HER2-negative breast cancer with mutations in HER2. Doctors are looking at whether people with a HER2 mutation might respond to the same treatment as people with HER2-positive breast cancer.

Neratinib is a drug which has been shown to be effective for treating HER2-positive breast cancer in clinical trials. The purpose of this research study is to test the cancer of women who are HER2-negative to see if it has a HER2 mutation and, if so, see how the cancer responds to neratinib. 

Neratinib is considered experimental, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) except in studies such as this one.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have tumor tissue tested for HER2 mutation.
  • Have completed radiation therapy.
  • Have metastatic (Stage IV) breast cancer.

You will be excluded from the study if any of the following criteria apply to you:

  • Are receiving any other investigational agents or systemic cancer therapy.
  • Have uncontrolled intercurrent illness.
  • Have acute or currently active hepatic or biliary disease.
  • Have a history of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.

This is a partial list of inclusion and exclusion criteria. 

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-8892
Contact Name: 
Jean Gibson