A Vaccine (ESR1 Peptide Vaccine) for the Treatment of Estrogen Receptor Positive Breast Cancer

Inclusion Criteria

• Patients with histologically confirmed, resected, breast cancer with one of the following characteristics: * pT3 or greater T stage with any N stage and M0 * pTxN+M0 (i.e., N1, 2 or 3)
• Human leukocyte antigen (HLA) A02+ and tumor is ER+
• Patients must have completed any standard chemotherapy recommended by their physician. There must be at least 4 weeks from their last dose of chemotherapy (or surgery if no chemotherapy was given) prior to the first dose of study vaccine. There should be no more than 2 years from the time of completion of any chemotherapy, surgery or HER2 targeted therapy. Ongoing endocrine therapies are permitted as long as they have been administered for at least 3 months prior to study enrollment
• Age >= 18 years
• White blood cell count (WBC) >= 3000/microliter
• Hemoglobin >= 9 g/dL
• Platelets >= 80,000/microliter
• Serum creatinine < 1.5 mg/dL
• Bilirubin < 1.5 mg/dL (except a bilirubin of < 2.0 will be permitted for patents with Gilbert’s syndrome)
• Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) =< 2 x upper limit of normal
• Ability to understand and provide signed informed consent that fulfills institutional review board’s guidelines

Exclusion Criteria

• Subjects with concurrent chemotherapy, radiation therapy, or immunotherapy are excluded. There must be at least 4 weeks between these prior therapy and study treatment. Subjects must have recovered from all acute toxicities from prior treatment. 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) test without other evidence of autoimmune disease will not exclude a subject for this study. A prior history of autoimmune hypothyroidism will not exclude a subject
• Subjects with serious intercurrent chronic or acute illness, such as cardiac disease, (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment
• Subjects with a medical or psychological impediment to probable compliance with the protocol should be excluded
• Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
• Known active acute or chronic infection including: an urinary tract infection, human immunodeficiency virus (HIV) (as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by western blot) or viral hepatitis (as determined by hepatitis B surface antigen [HBsAg] and hepatitis C serology). Subjects with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; subjects with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections
• Subjects on oral or intravenous steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Subjects must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-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 peptide injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded
• Splenectomy