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

NCT04144023 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Breast Ductal Carcinoma In Situ

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Amy C. Degnim, M.D. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144023 on ClinicalTrials.gov