A Phase II Trial of HKI-272 (Neratinib) and Capecitabine for Patients withHuman Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast cancerand Brain Metastases
The purpose of this research study is to find out if a drug called neratinib when given with capecitabine 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. Capecitabine is approved by the FDA for the treatment of breast cancer. The FDA is allowing the use of capecitabine in combination with neratinib in this research study. 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 begin treatment on one of the two arms of the study. One arm is for patients who will have surgery to remove the tumor in the brain, and the other arm is for patients who are not planned to have surgery. If you are not having surgery, you will come to clinic on the first day of the study to start neratinib and capecitabine, and have research blood work drawn. Treatment cycles for this study are 21 days.Neratinib will be taken every day and Capecitabine will be taken for 14 out of 21 days. If you are a patient for whom surgery is planned, 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 daily neratinib once you recover from your surgery. Patients on both arms will have scans to see how their breast cancer is responding, and will stay on treatment as long as the tumor in their brain stays the same or gets better (or does not come back after surgery). If the patientâ??s cancer in other parts of their body gets worse while on treatment, we have the option of adding herceptin to the treatment. The Herceptin will be given intravenously (IV) in the clinic every 21 days. All participants will complete study drug diaries and have research blood tests collected at the beginning and end of the study.
03/10/2014 04:02 AM