Personalized DNA Vaccine in Treating Patients with Triple-Negative Breast Cancer following Chemotherapy

Inclusion Criteria

• Histologically confirmed diagnosis of invasive breast cancer
• Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor; patients not meeting this pathology criteria, but have been clinically treated as having triple negative breast cancer (TNBC), can be enrolled at principal investigator (PI) discretion
• Human epidermal receptor 2 (HER2) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+
• Consented for genome sequencing and database of Genotypes and Phenotypes (dbGAP)-based data sharing and has provided or will provide germline and tumor DNA samples of adequate quality for sequencing; fresh tissue is preferred (from biopsy at the time of port placement) but archival tissue is allowed
• Clinical stage T1c-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging prior to neoadjuvant chemotherapy, with residual invasive breast cancer after neoadjuvant therapy; if the patient has invasive cancer in the contralateral breast, she is not eligible for this study
• Completed all standard of care therapy (surgery + radiation as clinically necessary) prior to vaccination
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• White blood cell (WBC) >= 3,000/uL (no more than 14 days prior to registration)
• Absolute neutrophil count >= 1,500/uL (no more than 14 days prior to registration)
• Platelets >= 100,000/uL (no more than 14 days prior to registration)
• Total bilirubin =< 2.5 x institutional upper limit of normal (no more than 14 days prior to registration)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (no more than 14 days prior to registration)
• Creatinine =< 1.5 x institutional upper limit of normal (no more than 14 days prior to registration)
• Women of reproductive 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
• Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria

• Evidence of progressive breast cancer within the last 30 days
• Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days (neoadjuvant chemotherapy excluded)
• Experiencing any clinically significant adverse events above grade 1 (according to Common Terminology Criteria for Adverse Events [CTCAE] 4.0) due to agents administered more than 30 days earlier; however, patients with grade 2 alopecia will be considered eligible
• Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days
• Known metastatic disease
• Invasive cancer in the contralateral breast
• Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (including sinus bradycardia), or psychiatric illness/social situation that would limit compliance with study requirements
• Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the PI to determine if eligible
• Pregnant or breastfeeding; a negative serum pregnancy test is required no more than 7 days before study entry
• The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor; a cancer survivor is eligible provided the following criteria are met: * Patient has undergone potentially curative therapy for all prior malignancies * Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix)
• Patient must have no active major medical or psychosocial problems that could be complicated by study participation
• Known human immunodeficiency virus (HIV)-positive status; these patients are ineligible because of the potential inability to generate an immune response to vaccines
• Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
• Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm
• Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
• Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
• Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, electrocardiogram (EKG), and/or laboratory screening test
• Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
• Syncopal episode within 12 months of screening
• Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators