Trial Information

Efficacy and Safety Study of NeuVax(TM) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)

This purpose of this study is to evaluate the safety and effectiveness of an investigational drug, NeuVax vaccine, in preventing the recurrence of node-positive, early stage breast cancer with low to intermediate Human Epidermal growth factor Receptor 2 (HER2).

Patient Inclusion Criteria:

Women, 18 years of age and higher
Pathological diagnosis of invasive adenocarcinoma of the breast
Breast cancer completely excised
Node-positive disease
Primary tumor stage T1-3
HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)
HLA-A2 or HLA-A3 haplotype
Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
Completed radiation therapy
No evidence of disease

Patient Exclusion Criteria:

Bilateral breast malignancy or suspicious mass in opposite breast
History of prior breast cancer, ductal carcinoma in situ
Prior trastuzumab therapy
New York Heart Association Stage 3 or 4 cardiac disease
Sensory/motor neuropathy ≥ Grade 2
Autoimmune diseases or immune deficiency disease
Patients on chronic steroid therapy, other immunosuppressive therapy

Christine Goetz, BA; CCRC
MultiCare Health System
314 Martin Luther King, Jr. Way, Suite 402
Tacoma, WA 98405
Phone: 253-403-7193
Email: Christine.Goetz@multicare.org

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Research Center Information: MultiCare Health System

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