This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient's own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers.

The vaccine in this trial has not previously been administered to humans, and therefore the induction of the desired immune responses in humans remains to be established. Patients will receive 6 intramuscular vaccinations over a 14 week period, with 9 clinic visits and 3 follow up visits. In addition, patients are asked to revisit the study physician once a year for 5 years after the study ends to evaluate any long-term effects.

Condition	Treatment or Intervention	Phase
Breast Cancer	Vaccine: Investigational Cancer Vaccine	Phase I

Ages Eligible for Study:  40 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Provide written informed consent.
• Previous diagnosis of HER2/neu-positive breast cancer.
• Stage II with 4 or more positive nodes, or Stage III in remission.
• Have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment with or without local-regional breast irradiation.
• Free of recurrent breast cancer disease.
• Current chest X-ray showing no evidence of disease.
• Completed at least one course of standard adjuvant treatment within 2 years of study entry.
• Life expectancy of at least 12 months.

Exclusion criteria:

• Surgery or chemotherapy treatment within 8 weeks of study enrollment.
• Radiotherapy within 12 weeks of study enrollment.
• Use of other experimental agents during study.
• Use of investigational or commercial agents or therapies intended to treat the malignancy during the study or within 1 month prior to first study vaccination.
• Patients younger than 40 years of age must be sterile or incapable of childbearing.
• Heart problems or uncontrolled hypertension, bleeding or coagulation disorders, auto-immune disorders, or psychiatric illness or addictive disorders.
• Known to be HIV positive.
• Past or current treatment with drug Herceptin.
• Pregnant or breastfeeding.
• Any uncontrolled illness that would preclude the study.

California
      Greenbrae,  California,  94904,  United States; Not yet recruiting
Florida
      Hollywood,  Florida,  33324,  United States; No longer recruiting
      Plantation,  Florida,  33324,  United States; Recruiting
Kentucky
      Louisville,  Kentucky,  40202,  United States; Suspended
Minnesota
      Rochester,  Minnesota,  55905,  United States; No longer recruiting
New York
      Buffalo,  New York,  14263,  United States; Recruiting
North Carolina
      Charlotte,  North Carolina,  28203,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  19111,  United States; Suspended
Washington
      Seattle,  Washington,  98195,  United States; Recruiting
Australia, Victoria
      East Melbourne,  Victoria,  VIC 3002,  Australia; Not yet recruiting
      Footscray,  Victoria,  VIC 3011,  Australia; Recruiting
      Parkville,  Victoria,  VIC 3050,  Australia; Not yet recruiting
      Heidelberg,  Victoria,  VIC 3084,  Australia; Recruiting
Belgium
      Brussels,  B-1000,  Belgium; Recruiting
      Brussels,  B-1200,  Belgium; Recruiting
      Leuven,  B-3000,  Belgium; No longer recruiting
      Leuven,  B-3000,  Belgium; Recruiting
Belgium, Hainaut
      Charleroi,  Hainaut,  B-6000,  Belgium; Recruiting
France
      Nantes-St-Herblain,  F-44805,  France; Recruiting
      Lyon Cedex 08,  F-69 373,  France; Recruiting
      Paris Cedex 05,  F-75 248,  France; Recruiting
Italy
      Roma,  I-00161,  Italy; Not yet recruiting
      Perugia,  I-06122,  Italy; Recruiting
      Milano,  I-20141,  Italy; Recruiting

Study ID Numbers:  719125/002
Record last reviewed:  October 2004
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058526
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10