A Phase II Trial of HKI-272 (Neratinib) for Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast cancer and Brain Metastases
The purpose of this research study is to find out if a drug called neratinib is helpful in the treatment of HER2-positive breast cancer that has spread to the brain. Neratinib is an experimental cancer drug taken by mouth that belongs to a class of drugs called tyrosine kinase inhibitors. Some participants in the study may also receive trastuzumab (Herceptin). Herceptin is an FDA approved drug for the treatment of HER2-positive breast cancer.
Patients who have HER2-positive breast cancer that has spread to the brain or patients with brain metastasis that has progressed after prior treatment that may or may not be having surgery may be eligible to join this study.
Before starting the study you will sign a consent form and undergo baseline testing including a doctorâ??s visit, blood and urine tests, heart function tests (including MUGA or echocardiogram and EKG), and scans of your brain and body. If these tests show that you are eligible, you will come to clinic to get your neratinib and have research blood work drawn. If surgery is planned to remove your brain tumor, you will take neratinib for 7-21 days before your surgery. At the time of your surgery, we will collect a piece of your tumor and or cerebral spinal fluid for the research study. You will restart neratinib after you recover from your surgery. You will have scans to see how your breast cancer is responding to the neratinib. You will stay on treatment as long as the tumor in your brain stays the same or gets better (or does not come back after surgery). If you have breast cancer in other parts of your body and that gets worse while on treatment, we have the option to give you herceptin in addition to the neratinib. The Herceptin will be given by intravenous (IV) in the clinic. All participants will complete study drug diaries and have research blood tests collected at the beginning and end of the study.
06/19/2013 04:02 AM