PURPOSE: @entity21867 (MAM-A) is overexpressed in 40% to 80% of primary @entity0 . We initiated a phase I clinical trial of a MAM-A DNA vaccine to evaluate its safety and biologic efficacy. EXPERIMENTAL DESIGN: @entity1 with @entity0 with stable metastatic disease were eligible for enrollment. Safety was monitored with clinical and laboratory assessments. The @entity405 T-cell response was measured by ELISPOT, flow cytometry, and @entity137 assays. Progression-free survival (PFS) was described using the Kaplan-Meier product limit estimator. RESULTS: Fourteen subjects have been treated with the MAM-A DNA vaccine and no significant adverse events have been observed. Eight of 14 subjects were HLA-A2(+), and the @entity405 T-cell response to vaccination was studied in detail. Flow cytometry demonstrated a significant increase in the frequency of MAM-A-specific @entity405 T cells after vaccination (0.9%    0.5% vs. 3.8%    1.2%; P < 0.001), and ELISPOT analysis demonstrated an increase in the number of MAM-A-specific IFNy-secreting T cells (41    32 vs. 215    67 spm; P < 0.001). Although this study was not powered to evaluate progression-free survival (PFS), preliminary evidence suggests that subjects treated with the MAM-A DNA vaccine had improved PFS compared with subjects who met all eligibility criteria, were enrolled in the trial, but were not vaccinated because of HLA phenotype. CONCLUSION: The MAM-A DNA vaccine is safe, capable of eliciting MAM-A-specific @entity405 T-cell responses, and preliminary evidence suggests improved PFS. Additional studies are required to define the potential of the MAM-A DNA vaccine for @entity0 prevention and/or therapy. Clin @entity5 Res; 20(23); 5964-75.   2014 AACR.

Safety and preliminary evidence of biologic efficacy of a mammaglobin-a DNA vaccine in @entity1 with stable metastatic XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['cytotoxicity'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancers', 'breast cancer'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity21867 :: ('MESH:D060785', 'Chemical') :: ['Mammaglobin-A'] @entity405 :: ('925', 'Gene') :: ['CD8']
@entity0 :: (MESH:D001943,Disease) :: ['breast cancer']
