RecruitingPhase 1NCT04144023

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


Sponsor

Mayo Clinic

Enrollment

43 participants

Start Date

Jun 27, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a vaccine called H2NVAC before surgery in people with ductal carcinoma in situ (DCIS) — a very early stage of breast cancer that has not spread — where the cancer cells have a protein called HER2 on their surface. The goal is to train the immune system to attack HER2-expressing cancer cells. **You may be eligible if...** - You have confirmed DCIS (non-invasive breast cancer) that has not yet been treated or surgically removed - Your tumor cells show HER2 expression at any level (1+, 2+, or 3+) - You have not previously received treatment for this DCIS - You are in good general health (ECOG performance status ≤ 2) - Your blood counts and organ function are within acceptable levels - You agree to use effective contraception from enrollment through 6 months after the final vaccination **You may NOT be eligible if...** - You are pregnant, breastfeeding, or unwilling to use contraception - You have an immunodeficiency condition or are on chronic steroids - You have HIV or an active autoimmune disease - You have another active cancer within the past 3 years - You have had prior radiation to the affected breast - Your heart function (LVEF) is below 55% - You have a known allergy to GM-CSF (an ingredient in the vaccine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGranulocyte-Macrophage Colony-Stimulating Factor

Given intradermally

BIOLOGICALMulti-epitope HER2 Peptide Vaccine H2NVAC

Given intradermally

PROCEDURETherapeutic Conventional Surgery

Undergo standard of care surgery

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBiopsy Procedure

Undergo biopsy


Locations(2)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT04144023


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