Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence - BR-HER-GP2-AE37

Phase 1

Conditions: Disease-free, conventionally treated node-positive and high-risk node-negative breast cancer patients who are at significant risk for recurrence.
MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

Registration Number: EUCTR2007-000934-38-GR

Lead Sponsor: Generex Biotechnology Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 600

Inclusion Criteria

1.NP or high-risk NN breast cancer patients. The latter is defined as any one of the following: T2, grade 3, lymphovascular invasion, ER/PR negative, or N0 (i+).
2.HER2/neu-expressing tumor (IHC 1-3+ and/or positive FISH >1.2)
3.Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients’ specific cancer)
4.Clinically cancer-free (no evidence of disease)
5.Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies.
6.Immunologically intact by recall anergy testing
7.Good performance status
8.Capable of informed consent

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.HER2/neu- breast cancers (IHC 0)
2.Clinical and/or radiographic evidence of residual or persistent breast cancer
3.Anergic by the Mantoux panel of recall antigens
4.Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
5.In poor health (Karnofsky <60%, ECOG >2)
6.Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
7.Active pulmonary disease requiring medication to include multiple inhalers
8.Pregnancy (urine HCG)
9.Breast feeding
10.History of autoimmune disease
11.Involved in other experimental protocols