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RECRUITING
NCT04144023
PHASE1

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2019-06-27

Completion Date

2027-12-31

Last Updated

2026-03-05

Healthy Volunteers

No

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

Locations (2)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States