What is the HER2 gene?

HER2 stands for Human Epidermal Growth Factor Receptor 2.  Each normal breast cell contains copies of the HER2 gene, which produces the HER2 protein.  The HER2 protein, also called the HER2 receptor, is found on the surface of some normal cells and helps send growth signals from outside the cell to the inside of the cell. These signals tell the cell to grow and divide.  Too much HER2 protein is thought to cause cancer cells to grow and divide more quickly

What is locally recurrent or metastatic breast cancer?

Locally recurrent breast cancer is cancer that has returned in the area of the original tumor after a period of remission in response to the initial treatment. Two-thirds of breast cancers that come back in the same breast return to the same place, or right near the original cancer. The other third are new cancers. Breast cancer in a separate part of the same breast, or in the other breast, is usually a new cancer.1 Metastatic breast cancer is the most advanced stage (stage IV) of breast cancer where the disease has spread beyond the original tumor site.

Why is this clinical research study important?

This research will be used to determine if an investigational medication, motesanib diphosphate (AMG 706), given in combination with chemotherapy can be used to control breast cancer growth. Motesanib diphosphate (AMG 706) is an investigational drug that is currently being evaluated for its potential ability to inhibit angiogenesis (blood vessel growth) by targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3).  Vascular endothelial growth factor receptors (VEGFR) play a critical role in tumor growth and metastasis by promoting the growth of blood vessels that supply required nutrients to cancer cells and allow for tumor expansion. Therapies that target the VEGFR pathway appear to neutralize these receptors, which are the main drivers of new blood vessel growth.  The most common side effects reported in clinical studies to date are fatigue, diarrhea, nausea, hypertension and headache.

Who is eligible to participate in this study?

This study is open to individuals who are at least 18 years-old, and have a diagnosis of HER2 negative locally recurrent or metastatic breast cancer that has not been been treated with chemotherapy or a VEGF inhibibitor.  Patients are allowed to have had prior endocrine therapy. Anyone with locally recurrent or metastatic HER2 negative breast cancer who meets the above-mentioned criteria is encouraged to contact the local study site in their area to discuss their eligibility: Pamela Riach, R.N., Ventura County Hematology-Oncology Specialists, (805) 485-8709.

How can patients get more information about the study?

To learn more about the study, patients can call the research nurse at their local study center: Pamela Riach, R.N., Ventura County Hematology-Oncology Specialists, (805) 485-8709. It is important to note that callers are under no obligation to enroll in the study.  During the phone call, the research nurse may ask questions about their medical history and may be able to schedule a visit to the study center.  At the time of this visit, the medical staff will continue to evaluate the patient’s eligibility to enroll.  However, a patient is under no obligation to enroll, even if they visit the study center.  Study enrollment is strictly voluntary and participants can discontinue participation at any time, for any reason.