Disease-free, conventionally treated node-positive and high-risk node-negative breast cancer patients who are at significant risk for recurrence. MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Product Name: HER2/neu, 654-661
Product Code: GP2
Pharmaceutical Form: Powder for injection*
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intrader
Sponsors
Generex Biotechnology Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To determine if the GP2 + GM-CSF vaccine reduces the recurrence rate in HLA-A2+, HER2/neu+, node-positive or high-risk node-negative breast cancer patients randomized to receive either the vaccine versus the immunoadjuvant, GM-CSF, alone. 2) To determine if the AE37 + GM-CSF vaccine reduces the recurrence rate in HLA-A2-, HER2/neu+, node-positive or high-risk node-negative breast cancer patients randomized to receive either the vaccine versus the immunoadjuvant, GM-CSF, alone. ;Secondary Objective: 1) To monitor the in vitro and in vivo immunologic responses to the vaccines and correlate these responses with the clinical outcomes. 2) To monitor for any unexpected toxicities with the vaccines. ;Primary end point(s): The purpose of this study is to determine if either or both of the peptides, GP2 and AE37, used as vaccines can prevent recurrence in disease-free, conventionally treated node-positive and high-risk node-negative breast cancer patients who are at significant risk for recurrence. Ultimately, we are interested in using these peptides in a highly efficient and clinically beneficial multi-epitope HER2/neu vaccine. | — |
Countries
Greece
Outcome results
None listed