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Title
Phase II Study of a HER-2/neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Stage IIIB and IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab Monotherapy
 
Study Design
Intradermal administration of 6 doses of a HER2 ICD peptide-based vaccine administered with a fixed dose of GM-CSF.
 
Study Contact
Nicole Bates | 866.932.8588 | E-Mail
 
Patient Population
  1. HER2-neu over-expressing
  2. Stage IIIB & IV Breast Cancer
  3. On maintenance Trastuzumab (less than 6 months)
  4. NED or Stable bone-only disease
Number of Patients: This study will accrue a maximum of 52 patients.
 
Patients Visits

  1. Total of 10 visits (the first 7 must be to Seattle)
  2. 1 Vaccination per month for 6 months
  3. Follow-up visits in months 7, 10, 14 & 18
    (Months 10, 14 & 18 can be done at local physician office)
  4. Yearly questionnaires to physician for up to 10 years
Other Procedures

  1. Tetanus Vaccine
  2. History & Physical
  3. MUGA (if not performed w/in 6 months)
  4. Leukapheresis
  5. Blood Tests
  6. Research Blood Draws
Objectives
Primary:
  1. Overall Survival
Other Notes
Patients can remain on Herceptin, hormonal therapy, and bisphosphanates while enrolled in the study.
 
Start Date: June 2006
 
Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195
 
Current Enrollment: 19%
 
Related Publications
Generation of T cell immunity to the HER-2/neu protein after active immunization with HER-2/neu peptide-based vaccines
Disis ML, Gooley TA, Rinn K, Davis D, Piepkorn M, Cheever MA, Knutson KL, Schiffman K
J Clinical Oncology 20(11): 2624-32, 2002
 
Scientific Description
 
ClinicalTrials.gov Identifier: NCT00343109
 
Page last updated 4/27/09