This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a consolidation therapy after neoadjuvant or adjuvant treatment of patients with Stage IIb-III triple negative breast cancer (TNBC).
Triple negative breast cancers (TNBCs) occur in approximately 20-25% of all patients with breast cancer and are associated with a poor prognosis. Patients with TNBCs derive no benefit from targeted therapies. Excluding those patients who demonstrate a pathologic complete response following neoadjuvant chemotherapy, which is a minor fraction (i.e. 15%), overall survival is only 45% at 7 years. Following standard of care, there are windows of opportunity to further and safely treat patients to prevent recurrence. Stimulating the immune system to produce T cells immunity specific for tumor antigens may significantly delay recurrence and cure patients. The proposed vaccine is intended to induce T cells to survey for the reemergence of TNBCs and to prevent recurrence in the adjuvant setting. The vaccine strategy is antigen-specific and targets the Folate Receptor Alpha (FRα). FRα is an ideal target because of its limited expression in the healthy tissues and it high expression in 86% of TNBCs. Studies have shown that it is a biologically important marker that is associated with poorer clinical outcome and is retained in metastatic lesions. The FRα vaccine include a pool of 5 peptides that are immunogenic epitopes and safely generate tissue-surveying CD4 T cell immune responses in patients tested in a recently completed phase I clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
165ug per peptide ID injection
IV infusion over 1 hour
500ug per peptide ID injection
Moffitt Cancer Center
Tampa, Florida, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, United States
Immune response
Emergence of B and T cell immunity targeting the folate receptor alpha
Time frame: 3 years
Folate receptor alpha expression
To determine FRα expression status of primary tumors
Time frame: Baseline
Relapse Free Survival
RFS in relation to FR specific immune response
Time frame: 3 years
Safety and tolerability (treatment emergent adverse events and injection site reactions)
Incidence of treatment emergent adverse events and injection site reactions
Time frame: 3 years
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Karmanos Cancer Center
Detroit, Michigan, United States
MidAmerica Division,Inc
Kansas City, Missouri, United States
The Valley Hospital
Paramus, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center, Einstein Cancer Center
New York, New York, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
...and 1 more locations