Vaccination of High Risk Breast Cancer Patients

Inclusion Criteria:

- Females of all races with clinical stage I, II, or III ER-positive breast cancer who
qualify for standard neoadjuvant treatment

- Age 18 years and older

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

- White blood cell (WBC) count ≥ 3,000/mm3 within 2 weeks prior to registration.

- Platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.

- Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL)
of normal obtained within 2 weeks prior to registration.

- Aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal
obtained within 2 weeks prior to registration.

- Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks
prior to registration.

- Serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.

- Must sign an informed consent approved by the University of Arkansas for Medical
Sciences (UAMS) Institutional Review Board (IRB).

Exclusion Criteria:

- Active infection requiring treatment with antibiotics.

- Diagnosis or evidence of organic brain syndrome that might preclude participation in
the full protocol.

- Diagnosis or evidence of significant impairment of basal cognitive function that might
preclude participation in the full protocol.

- No other current malignancies. Subjects with prior history at any time of any in situ
cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ,
atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin
cancer are eligible, provided they are disease-free at the time of registration.
Subjects with other malignancies are eligible if they have been continuously disease
free for ≥ 5 years prior to the time of registration.

- Autoimmune disorders or conditions of immunosuppression. This includes, but is not
limited to being treated with corticosteroids, including oral steroids (i.e.
prednisone, dexamethasone [except when used as an antiemetic in standard therapy]),
continuous use of topical steroid creams or ointments or any steroid-containing
inhalers. Subjects who discontinue the use of these classes of medication for at least
6 weeks prior to registration are eligible if, in the judgment of the treating
physician, the subject is not likely to require these classes of drugs during the
treatment period. Replacement doses of steroids for subjects with adrenal
insufficiency are allowed.

- Pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines
on a fetus or infant). Women of childbearing potential must have a negative urine
pregnancy test within 72 hours prior to receiving the first dose of study drug and
must be counseled to use an accepted and effective method of contraception (including
abstinence) while on treatment and for a period of 18 months after completing or
discontinuing treatment. Accepted methods of contraception include oral
contraceptives, barrier methods, Intrauterine Device (IUDs), and abstinence.

- Any other significant medical or psychiatric conditions which, in the opinion of the
enrolling investigator, may interfere with consent or compliance of the treatment
regimen.