A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA)
The purpose of this study is to determine whether using the experimental drug, neratinib, with capecitabine is safe and more beneficial than treatment with lapatinib and capecitabine. Neratinib is an experimental anti HER2+ drug that is taken orally. Capecitabine is an approved chemotherapy pill used for the treatment of metastatic breast cancer. Lapatinib is a HER2 targeted drug that is approved in combination with capecitabine for the treatment of HER+ metastatic breast cancer.
Patients with HER2 positive metastatic breast cancer (MBC) who have received at least two previous anti HER2 treatments for MBC may be eligible.
You will sign consent, have scans, tests and lab work to make sure that it is safe for you to participate in the trial; the research staff will review the specific requirements with you in detail. Some tumor tissue from your metastatic cancer will need to be tested for HER2 expression in a central lab. If we do not have access to that tissue, you will need to have a biopsy to obtain tissue in order for you to participate in the study. Once it is determined you are eligible for the study, you will then be randomized (chosen by random, like flipping a coin) to treatment with either neratinib and capecitabine or lapatinib and capecitabine. You will know which treatment you are getting and the study staff will review your dosing schedules with you. During the first cycle, you will come to the clinic weekly for three weeks in a row. You may need to remain in the clinic on the first and 15th days of treatment to have research blood samples taken for about 8 hours after your study treatment dose. The research staff will let you know if this applies to you. You will then return to clinic at the beginning of each cycle (every 3 weeks) to be given a new supply of study medication and for follow up exams and tests. As part of this study you will be asked to fill out questionnaires about your general health status before you start and periodically while you are being treated. Scans will be repeated every 6 weeks and you will continue on study as long as you are tolerating the treatment and your cancer is responding.The study drug, neratinib, will be supplied by the study. We will provide you with additional information about which tests, drugs and procedures will be paid for by the study and which will be billed to your insurance company
09/15/2014 04:03 AM