Stage IV, HER2-Negative Women Needed for Trial Testing Neratinib

Hortense

At the suggestion of the moderators, I am posting this email I received from an Army of Women about a Stage IV study. I believe you will have to go to the website to be able to click on through to sign up.

http://mailing.armyofwomen.org/form/armyofwomen/viewhtml/9z1z42cnu818hv5fjs894l9nu5bfo1804n1g2boo3lg

Stage IV, HER2-Negative Women Needed for Trial Testing Neratinib We need women throughout the United States who have HER2-negative metastatic breast cancer to take part in a phase II study of the experimental drug neratinib. We have recruited for this study in the past but the research team still needs more women to sign up! Neratinib works by attaching itself to the HER2 receptor. It was initially developed for and studied in women with HER2-positive metastatic breast cancer. However, laboratory and early studies suggest it may also be effective in the small group of women whose tumors have a specific type of HER2 mutation but test HER2-negative on current tumor tests. Please read on to learn more about what's involved and who can participate. If this study isn't right for you, we hope you will pass this email on to someone you know who might qualify. WHAT'S THE STUDY ABOUT? The purpose of this study is to see whether neratinib is effective in treating HER2-negative metastatic tumors that have this specific HER2 mutation. The first part of the study is a preliminary screening. During this part of the study, your tumor tissue will be tested to see if it has the HER2 mutation the researchers are looking for. If your tumor has the mutation, you will be given more information about the main research study, which is investigating the effectiveness of neratinib. WHAT'S INVOLVED? If you sign up for this study, "A Phase II Study of Neratnib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer," a research coordinator will send a consent form to you and: • Ask you to obtain medical records from your doctor's office • Send the records to the research team at no cost to you • Evaluate your overall health based on medical records provided by your doctor's office. Based on this information, the research coordinator will determine if you are eligible to have your tumor tissue (either from a new biopsy or previous biopsies) tested for the HER2. It will take 3-4 weeks for you and your research study doctor to learn whether your tumor has the specific HER2 mutation the researchers are studying. If it does, your research study doctor will give you more information about the research study so that you can decide if you want to enroll. If the tumor does not have this HER2 mutation, you will not be eligible for the main research study. However, information about your medical history and tumor characteristics as well as any samples collected up to this point might still be analyzed as part of this study. WHO IS CONDUCTING THE STUDY? Cynthia Ma, M.D., Ph.D., Washington University, St Louis, MO WHERE? The screening is being conducted through Washington, University, St. Louis, MO. If your tumor is found to have the HER2 mutation the researchers are studying and you are eligible and interested in receiving neratinib through the trial, you will be referred to the cancer center nearest you that is participating in the study to receive treatment. WHO CAN PARTICIPATE? You can join the Phase II Study of Neratnib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer if you match ALL of these main categories: • You are a women with confirmed stage IV breast cancer that is HER2-negative (0 and 1+ by IHC or non-amplified by FISH). • You do not have a history of heart problems. • You do not require oxygen. • You do not have abnormal liver or kidney function. • You are able to participate in activities without significant restriction. Please note that these are only the PRELIMINARY eligibility criteria and the research team will ask you additional questions to be sure that this study is a right fit for you. Yes, Sign Me Up No Thanks Recruit a Friend