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Brief Title: Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer
Official Title: A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer
Study ID: NCT04270149
Brief Summary: This is a phase I study looking at the safety of cancer peptides combined with adjuvant and GM-CSF in subjects with estrogen receptor (ESR) positive breast cancer. The primary objective of the study is to determine the safety of of the peptide vaccine. The secondary objective is to evaluate the immune response to the vaccine. The peptides used in this vaccine are derived from the estrogen receptor and are combined with the adjuvant Montanide ISA and GM-CSF to enhance their immune response. A peptide vaccine of these peptides may improve outcomes of patients with endocrine resistant breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Duke University Medical Center, Durham, North Carolina, United States