Personalized Dendritic Cell Vaccine for Treatment of High Risk Triple Negative Breast Cancer Patients Who Received Chemotherapy before Surgery, Precision DC Trial

Inclusion Criteria

• Patient has stage II-III estrogen receptor (ER)/progesterone receptor (PR) =< 10% human epidermal growth factor receptor 2 (HER2) – by fluorescence in situ hybridization (FISH) and/or immunohistochemistry (IHC) breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to residual cancer burden [RCB] II or III) disease.
• Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.
• Patient is deemed to be in a suitable medical condition to undergo pheresis by treating physician and/or principal investigator.
• Age 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Absolute neutrophil count >= 1,000/mcL.
• Platelets >= 100,000/mcL.
• Total bilirubin =< 1.5 X institution upper limit of normal (ULN).
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional ULN.
• Glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2.
• Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.
• The effects of the DC1 vaccine on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Patients with known active locally advanced unresectable or metastatic cancer.
• Participants with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the principal investigator (PI).
• Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.
• Participants who are currently receiving any other investigational agents.
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study.