Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer

Inclusion Criteria

• •1. Female patient, age 18 years or older;
• •2. Completely resected unilateral or bilateral primary carcinoma of the breast
• •3. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
• •4. Primary tumor was negative for ER, PR (cut-off for positivity is \>10% positive tumor cells with nuclear staining) and negative for Her2-neu (0 or 1+ on immunohistochemistry and/or normal gene copy number by in-situ hybridization); Central review is not required.
• •5. Completed primary treatment (surgery and radio/chemotherapy in adjuvant and/or neo-adjuvant setting) \<360 days prior to first vaccination.
• •6. Completed last cycle of chemotherapy or radiation \> 60 days prior to first vaccination
• •7. Either clinical or pathological Stage I (T1c), II, or III according to AJCC 7th edition
• •* Note that patients with (i) non-invasive breast cancer (DCIS) alone, (ii) incidental (microscopic) nodal cancer without a primary tumor (pN1mi), or (iii) metastatic disease are excluded.
• •* Resected tumor: No evidence of gross tumor at the surgical resection margin noted in the final surgery report. No evidence of gross residual adenopathy
• •8. Karnofsky index \>= 70%;
• •9. Life expectancy of at least 5 years, disregarding the diagnosis of cancer;
• •10. Adequate Blood, renal and hepatic function, as determined within 28 days from registration:
• •* ANC ≥ 1,500 / mm3
• •* Platelet ≥ 100,000 / uL
• •* Hgb \> 9 g/dL
• •* Creatinine ≤ 1.5 x ULN or 24-hour urine \< Grade 2
• •* Urinalysis with \< 2+ proteinuria
• •* Serum albumin ≥ 3 g/dL
• •* SGOT (AST) ≤ 3 x ULN
• •11. Anti-nuclear antibody (ANA) negative or low-positive institutional range, as determined within 28 days from registration. Intermediate values (usually defined by a titer of ≤1:80, or as indicated by institutional range) are acceptable if there are, in the opinion of the Investigator, no early signs of an autoimmune disease.
• •12. Primary tumor is available for shipment to central laboratory for analysis of FRα expression by IHC.
• •13. Patients must be, in the opinion of the Investigator, available and compliant for treatment and follow-up.