5215W-12: Kaplan Galena PRESENT

CRC 11105: Prevention of Recurrence in Early-Stage,Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment

Type of Study
Cancer (Oncology) - Breast
Swedish Cancer Institute
Short Description

Purpose: To assess the efficacy and safety of NeuVax(TM)a peptide (E75) vaccine administered with adjuvant Leukine(R)(sargramostim,GM-CSF). To evaluate and compare the disease free survival (DFS) in the vaccinated patients and control patients.

Open to Enrollment
Principal Investigator
Kristine Rinn, M.D. and Henry Kaplan, M.D.
Eligibility Notes
  • 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 prior neo-adjuvant/adjuvant chemotherapy or both
  • Completed radiation therapy
  • No evidence of disease
  • No prior history of breast cancer, ductal carcinoma in situ
  • No prior trastuzumab therapy
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086