Vaccination of High Risk Breast Cancer Patients

After signing Institutional Review Board (IRB) approved consent, cohorts of 3-6 stage IV
breast cancer subjects will be enrolled into the study. The vaccine doses will be prepared
and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following
the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous (SC) injections of
the vaccine on 5 separate occasions during Weeks 1, 2, 3, 7, and 19. The first cohort will
begin with the 300 mg dose, and then the subsequent cohorts will escalate to 500 mg or
de-escalate to 100 mg as determined by the toxicity criteria. The immunization at week 19 is
considered a booster immunization. The vaccine will be administered at rotating sites on the
limbs or abdomen. The study will last for approximately 12 - 24 months.

Inclusion Criteria:

- Female subjects of all races with histologically or cytologically confirmed stage IV
breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed
after primary or adjunctive therapy and must not have required a treatment change for
2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The
chemotherapy regimen cannot contain steroids in the pre or post supportive care
medications. If a subject is on an investigational drug, the drug must be cleared from
the body over a period of 4 weeks.

- Disease staging will be done according to the American Joint Commission on Cancer
(AJCC), sixth edition.

- Age 18 years and older of all races and ethnicity.

- ECOG Performance Status 0 or 1.

- Subjects must not have an active infection requiring treatment with antibiotics.

- Subjects must not have other significant medical, surgical or psychiatric conditions,
or require any medication or treatment, which may interfere with compliance of the
treatment regimen.

- Subjects must not have a diagnosis or evidence of organic brain syndrome, significant
impairment of basal cognitive function or any psychiatric disorder that might preclude
participation in the full protocol.

- Subjects must have 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.

- Subjects must not have autoimmune disorders or conditions of immunosuppression. This
includes, but is not limited to being treated with corticosteroids, including oral
steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or
ointments or any steroid-containing inhalers. Subjects who have been on systemic
steroids will require a 6-week washout period. 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.

- Women of childbearing potential must not be pregnant (negative serum pregnancy test
must be done 48 hours prior to receiving the first dose of study drug) or
breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or
infant.

- Women of childbearing potential 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 include oral
contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.

- Subjects must have obtained a white blood cell (WBC) count ≥ 3,000/mm3 and platelet
count ≥ 100,000/mm3 within 2 weeks prior to registration.

- Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate
aminotransferase test (AST) and bilirubin ≤ 2 x institutional upper limit (IUL) of
normal and serum creatinine ≤ 1.8 mg/dl, all obtained within 2 weeks prior to
registration.

- Subjects must be immunocompetent as measured by responsiveness to two recall antigens
by skin testing.

- All subjects who wish to participate in the study must sign an informed consent
approved by the UAMS Institutional Review Board (IRB).

- Laboratory tests must be completed within 2 weeks before the first dose.