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Neratinib for Metastatic HER2 Mutation Breast Cancer [WASHU] - Clinical Trial

What is the Purpose of this Study?

This study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib (study drug).

What is the Condition Being Studied?

Metastatic HER2 Negative Breast Cancer

Who Can Participate in the Study?

Adults who:
- Have Stage IV (4), HER2 negative breast cancer
- Have tested positive for the HER2 mutation.

There is no limitation on the number of prior lines of chemotherapy.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Submit a previously collected breast tissue sample to be tested for HER2 mutation status
--- If you have the HER2 mutation, you will continue onto the study and get a daily dose of the study drug, neratinib in 28day cycles until your disease gets worse, you show bad side effects, or your doctor doesn't want you to be in the study anymore.
-Have tests, exams, and procedures that are part of your standard care and for study purposes

Study Details

Full Title
A Phase II Study of Neratinib Alone and in Combination with Fulvestrant in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00045798
NCT:NCT01670877
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698