Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer

Inclusion Criteria:

• Patients with histologically confirmed, resected, breast cancer with one of thefollowing characteristics:

pT3 or greater T stage with any N stage and M0 pTxN+M0 (i.e., N1,2 or 3)

• HLA A0201+ and tumor is ER+

• Patients must have completed any standard chemotherapy recommended by theirphysician. There must be at least 4 weeks from their last dose of chemotherapy (orsurgery if no chemotherapy was given) prior to the first dose of study vaccine.There should be no more than 5 years from the time of completion of anychemotherapy, surgery or HER2 targeted therapy. Ongoing endocrine therapies arepermitted as long as they have been administered for at least 3 months prior tostudy enrollment.

• Age ≥ 18 years.

• Heme: WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, platelets ≥ 80,000/microliter.

• Adequate, renal and hepatic function with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except a bilirubin of <2.0 will be permitted for patents with Gilbert'ssyndrome), SGOT/SGPT < 2 x upper limit of normal.

• Ability to understand and provide signed informed consent that fulfillsInstitutional Review Board's guidelines.

Exclusion Criteria:

• Subjects with concurrent chemotherapy, radiation therapy, or immunotherapy areexcluded. There must be at least 4 weeks between these prior therapy and studytreatment. Subjects must have recovered from all acute toxicities from priortreatment. Peripheral neuropathy grade 1 due to prior therapy will be permitted.

• Subjects may not have history of distant metastases.

• Subjects with a history of autoimmune disease, such as but not restricted to,inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,scleroderma, or multiple sclerosis. A positive ANA (anti-nuclear antibody) testwithout other evidence of autoimmune disease will not exclude a subject for thisstudy. A prior history of autoimmune hypothyroidism will not exclude a subject.

• Subjects with serious intercurrent chronic or acute illness, such as cardiacdisease, (NYHA class III or IV), hepatic disease, or other illness considered by thePrincipal Investigator as unwarranted high risk for investigational drug treatment.

• Subjects with a medical or psychological impediment to probable compliance with the

• Concurrent (or within the last 5 years) second malignancy other than non-melanomaskin cancer, cervical carcinoma in situ, controlled carcinoma in situ of the cervix,or controlled superficial bladder cancer.

• Presence of an active acute or chronic infection including: an urinary tractinfection, HIV (as determined by ELISA and confirmed by Western Blot) or viralhepatitis (as determined by HBsAg and Hepatitis C serology). Subjects with HIV areexcluded based on immuno-suppression, which may render them unable to respond to thevaccine; subjects with chronic hepatitis are excluded because of concern thathepatitis could be exacerbated by the injections.

• Subjects on steroid therapy (or other immuno-suppressives, such as azathioprine orcyclosporin A) are excluded on the basis of potential immune suppression. Subjectsmust have had 6 weeks of discontinuation of any steroid therapy (except that used aspre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.

• Subjects with allergies to any component of the vaccine

• Pregnant or nursing mothers.

• Subjects with acute or chronic skin disorders that will interfere with peptideinjection into the skin of the extremities or subsequent assessment of potentialskin reactions will be excluded.

• Splenectomy