Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

Inclusion Criteria

• •HLA-A\*02-positive, unless being enrolled in the third non-HLA-A\*02 arm
• •Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous contralateral disease)
• •Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
• •Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy
• •The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy.
• •No clinical evidence of residual or persistent breast cancer per treating physician assessment
• •ECOG 0-2
• •Adequate organ function
• •Negative pregnancy test or evidence of post-menopausal status
• •If of childbearing potential, willing to use a form of highly effective contraception
• •Subject must both reside in and have been treated for their cancer in the country in which the clinical site is located.