Mayo Clinic
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 neoadju…
Inclusion Criteria: * 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 tamox…
Given intradermally
Given intradermally
Undergo standard of care surgery
Undergo ECHO
Undergo collection of blood samples
Undergo biopsy
Arctuva estimate
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