The most important consideration in the design of this clinical trial is to ensure the safe translation of the personalized synthetic long peptide vaccine strategy. The Food and Drug Administration (FDA) dictates that initial studies of biologic therapies be performed in such a way that there is a balance between the potential risks and benefits in individual patients. Consistent with these recommendations, the investigators will target patients with triple-negative breast cancer who do not have a pathologic complete response after neoadjuvant chemotherapy. These patients typically have no gross evidence of disease following standard of care therapy (neoadjuvant chemotherapy, surgery and radiation therapy) but are at extremely high-risk for disease recurrence. Targeting this patient population provides a window-of-opportunity to design and manufacture the personalized cancer vaccines, maximizes the potential benefit from the vaccine as the regulatory networks associated with metastatic disease are not present, and balances risk in this patient population with extremely high risk for disease recurrence but no other treatment options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Safety of the vaccine regimen as measured by grade and frequency of adverse events
-Toxicity will be characterized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE). -Subjects who are immunized with the synthetic long peptide vaccine will be evaluated at the time of each vaccination. Follow-up on subject well-being will be performed by telephone on the first or second day after each vaccination.
Time frame: 1 year
Immunogenicity of the vaccine regimen as measured by ELISPOT analyses
* ELISPOT analyses is a surrogate for CD8 T cell function * The quantity and quality of antigen-specific CD8 T cells is determined * The ELISPOT analysis is based on measuring the frequencies of IFN-γ producing T cells in response to polyepitope antigen
Time frame: 1 year
Immunogenicity of the vaccine regimen as measured by multiparametric flow cytometry
* Multiparametric flow cytometry is a surrogate for CD8 T cell function * The quantity and quality of antigen-specific CD8 T cells is determined * Multiparametric flow cytometry assesses phenotypic as well as functional characteristics of epitope-specific CD8 T cells
Time frame: 1 year
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