This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.
PRIMARY OBJECTIVE: I. Evaluate for nelipepimut-S-specific cytotoxic T lymphocyte (CTL; cluster of differentiation \[CD\]8+ T cell) response in patients receiving NeuVax (nelipepimut-S plus GM-CSF \[sargramostim\]) compared to patients receiving GM-CSF alone (control). SECONDARY OBJECTIVES: I. Toxicity profile and frequency of adverse events in women with ductal carcinoma in situ (DCIS) of the breast receiving nelipepimut-S vaccine as compared to women receiving GM-CSF alone. II. Presence of DCIS at resection. III. Difference in HER2 expression in the biopsy and the surgical specimen excised post-vaccination. IV. Histologic responses: IVa. Degree of lymphocyte infiltration determined on hematoxylin and eosin (H\&E) stained slides and immune infiltration as determined by multiplex immunofluorescence staining for markers including but not limited to CD3, CD4 and CD8. IVb. Immune infiltrates in normal tissue maximally distant from the tumor (in mastectomy samples). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nelipepimut-S plus GM-CSF vaccine intradermally (ID) on days 0 and 14 and then undergo surgery on day 28. ARM II: Patients receive sargramostim ID on days 0 and 14 and then undergo surgery on day 28. After completion of study treatment, patients are followed up at 1 and 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
43
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
Mean Percent of Nelipepimut-S-specific Cytotoxic T Lymphocyte Response (E75)
Change from baseline in the Mean percent of Nelipepimut-S-specific cytotoxic T lymphocyte response one-month post-surgical resection. Wilcoxon rank sum test exact P-value was used.
Time frame: One-Month post-surgical resection from baseline
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs) Within the Basement Membrane
Change from baseline in the iTILs at surgical resection. Wilcoxon rank sum test exact P-value was used.
Time frame: Baseline to surgical resection, up to 5 weeks
Intra-tumoral Tumor-infiltrating Lymphocytes (iTILs)
Change from baseline in the iTILs at surgical resection. Wilcoxon rank sum test exact P-value was used.
Time frame: Baseline to surgical resection, up to 5 weeks
Number of Participants With HER2 Expression in Biopsy and Resection Specimens
Difference in HER2 Expression in Biopsy and Resection Specimens. Differences were assessed using a Fisher's exact test.
Time frame: Baseline to surgical resection, up to 5 weeks
Number of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
The number of serious and non serious adverse events for both arms. Graded According to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03.
Time frame: 3-6 months after surgery
Number of Participants With Presence of Ductal Carcinoma in Situ (DCIS)
Presence of DCIS with Invasive Cancer.
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Undergo surgery
Time frame: At resection