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Brief Title: Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy
Official Title: A Phase 1B Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in ER+, HER2- Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy or Chemotherapy
Study ID: NCT02204098
Brief Summary: The purpose of this research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer. 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. There is evidence that an immune response may be a way to fight cancer. In addition to evaluating the safety of the mammaglobin-A injection, this study is also looking at the immune response that the participant's body has after each injection.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Washington University School of Medicine, Saint Louis, Missouri, United States
Name: William Gillanders, M.D.
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR