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.
PRIMARY OBJECTIVES: I. To determine the safety and tolerability of multi-epitope HER2 peptide vaccine H2NVAC (H2NVAC) given for 4 treatments in patients with HER2-expressing ductal carcinoma in situ (DCIS) prior to surgery. II. To determine the dose level of H2NVAC with maximum systemic and intratumoral immunogenicity as measured by activated HER2-specific T lymphocytes or high-affinity antibodies. SECONDARY OBJECTIVES: I. To determine intratumoral immunogenicity of H2NVAC in patients with HER2-expressing DCIS. II. To assess the complete pathological response after 4 treatments of neoadjuvant H2NVAC. III. To assess the systemic immunogenicity of H2NVAC in patients with HER2-expressing DCIS. IV. To assess changes in HER2 expression in the DCIS after 4 treatments of neoadjuvant H2NVAC. V. To assess the distribution of the helper T cell response among T helper cell differentiation states. OUTLINE: This is a dose-escalation study of multi-epitope HER2 peptide vaccine H2NVAC followed by a dose expansion study for dose level. Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive granulocyte macrophage-colony-stimulating factor (GM-CSF) admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo echocardiography (ECHO) and collection of blood samples throughout the trial and may undergo biopsy on trial. After completion of study treatment, patients are followed up at 3, 6, and 12 months after surgery and optionally at 18 and 24 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Given intradermally
Given intradermally
Undergo standard of care surgery
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGMayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGAdverse events
Number of adverse events reported, measured using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Time frame: 2 years
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.
Time frame: 14 days post vaccination, 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Undergo ECHO
Undergo collection of blood samples
Undergo biopsy