A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS
This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Patients must not have received any prior therapy for current DCIS
‣ Note: Patients who received tamoxifen, raloxifene, aromatase inhibitor or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least 2 months prior to baseline study biopsy if they chose to have this collected
⁃ Note: Concurrent use of endocrine therapy during the vaccination/preoperative period is not allowed. However, standard adjuvant endocrine therapy with tamoxifen or aromatase inhibitor after completion of vaccination and surgery is allowed
• Any degree of HER2 expression as performed on the diagnostic clinical biopsy defined by immunohistochemistry +1, +2, or +3
• Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis
‣ Note: suspected microinvasion or definite microinvasion (\< 0.1 mm invasion) on core biopsy is allowed
• Patients will be asked to have an additional research biopsy prior to the first vaccination. This is not mandatory for participation
• Patients must have evidence of at least 0.5 cm of disease extent based on mammogram, ultrasound, or magnetic resonance (MRI) imaging
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (less than or equal to 28 days prior to registration)
• Platelet count \>= 75,000/mm\^3 (less than or equal to 28 days prior to registration)
• Hemoglobin \>= 9.0 g/dL (less than or equal to 28 days prior to registration)
• Creatinine =\< 2 x upper limit of normal (ULN) (less than or equal to 28 days prior to registration)
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2 x ULN (less than or equal to 28 days prior to registration)
• Albumin \>= 3 g/dL (less than or equal to 28 days prior to registration)
• Negative serum pregnancy test done =\< 7 days prior to Registration, for women of childbearing potential only
• Willing to employ adequate contraception from the time of Registration through 6 months after the final vaccine cycle
‣ Note: Adequate contraception methods include birth control pills, barrier device, intrauterine device, or abstinence
• Capable of understanding the investigative nature, potential risks, and benefits of the study
• Capable of providing valid informed consent
• Willing to return to enrolling institution for all study visits (immunizations, blood draws, etc)
• Willing to provide blood samples for correlative research purposes
• Willing to receive a tetanus vaccination if subject has not had one within the past year