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A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Mammaglobin-A DNA Vaccine in Breast Cancer Patients with Metastatic Disease
The overall goal of this study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into patients with breast cancer. DNA is material that contains the information needed to produce many substances in the body. The DNA used in this study was purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way to generate an immune response to breast cancer cells. An immune response is the way your body fights viruses and other infections. There is evidence that an immune response may be a way to fight cancer.
The study injections are considered investigational (not approved by the U.S. Food and Drug Administration). There is no evidence yet that an injection of mammaglobin-A results in any clinical benefit. You will be in the first group of humans tested with mammaglobin-A DNA.
The main purpose of this study is to demonstrate the safety of the experimental DNA vaccine. This study is not designed to determine whether injection of DNA has anti-breast cancer effects. Based on laboratory experiments, we believe that injection of DNA could result in the production of an immune
response (T-cells) that recognize breast cancer cells. T–cells are a type of white blood cell that can fight infections and possibly cancer.
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