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NCT number NCT03289039
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Heather A. Parsons, MD
Phone 617-632-3800
Email HeatherA_Parsons@dfci.harvard.edu
Status Not yet recruiting
Phase Phase 2
Start date September 30, 2017
Completion date March 31, 2025

Clinical Trial Summary

This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer .

The interventions involved in this study are:

- Neratinib and Fulvestrant

- Neratinib alone


Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has approved Neratinib as a treatment for breast cancer. Fulvestrant has been FDA approved for treatment of metastatic hormone receptor positive breast cancer.

The purpose of this research study is to determine how well neratinib, by itself or together with Fulvestrant, works in treating breast cancer that has spread to other parts of the body. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2).

Neratinib has been used in other research studies and information from those other research studies suggests that neratinib may help to shrink or stabilize HER2-positive breast cancer in this research study.


Study Design


Related Conditions & MeSH terms


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