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
Pregnant women
Nursing women unwilling to stop breast feeding
Women of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Single group
Granulocyte-Macrophage Colony-Stimulating Factor
Biological/VaccineGiven intradermally
Multi-epitope HER2 Peptide Vaccine H2NVAC
Biological/VaccineGiven intradermally
Therapeutic Conventional Surgery
Procedure/SurgeryUndergo standard of care surgery
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Adverse events
Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Dose limiting toxicities
Measured using criteria from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 with grade \>= 3 allergic reaction, grade \>= 3 autoimmune reaction (except for autoimmune encephalitis grade \>=4), grade \>= 3 injection site reaction manifesting as an ulceration, grade \>= 3 neurologic problem, grade \>= 3 non-hematologic or cardiac toxicity, or changes in left ventricular ejection fraction (LVEF) as specified per protocol.
Click on the lead sponsor to view all of their trials.
