NCT04144023

A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Ductal Carcinoma In Situ

Interventions

Type	Name	Description
BIOLOGICAL	Granulocyte-Macrophage Colony-Stimulating Factor	Given intradermally
BIOLOGICAL	Multi-epitope HER2 Peptide Vaccine H2NVAC	Given intradermally
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care surgery
PROCEDURE	Echocardiography Test	Undergo ECHO
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Biopsy Procedure	Undergo biopsy

Timeline

• Start date: 2019-06-27
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2019-10-30
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study