A Phase II Study of Neratinib to Treat Metastatic Breast Cancer that Does Not Overexpress HER2 but Has a HER2 Mutation

Protocol
13-195
Full Title
A Phase II Study of Neratinib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
Phase
II
Purpose

HER2 is a protein which, when abnormal (mutated), can fuel cancer growth. Many breast cancers overproduce this protein. They may be treated with drugs that target HER2, like trastuzumab or lapatinib.

Some women with breast cancer test negative for HER2 overexpression but have mutations in the HER2 gene. Doctors want to know if they might also benefit from therapies that target HER2.

In this study, researchers want to evaluate the safety and effectiveness of neratinib in women with metastatic breast cancer that does not overexpress the HER2 protein but contains a mutation in the HER2 gene. Neratinib is an investigational drug that blocks some of the functions of the HER2 protein. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic breast cancer that does not overexpress the HER2 protein but contains a mutation in the HER2 gene.
  • Patients must have recovered from the serious side effects of prior therapies before entering the study.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Shanu Modi at 646-888-5243.

Disease(s)
Breast Cancer
Locations
Related Diseases