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Therapeutic Areas: Oncology | Obstetrics/Gynecology (Women’s Health) | Family Medicine
Disease Category: Breast Cancer
Location: United States, WA

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

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

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Research Center Information: MultiCare Health System

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183315

Date Last Changed: September 17, 2012


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