RecruitingPhase 2NCT04329065

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer

A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy


Sponsor

University of Washington

Enrollment

25 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an experimental cancer vaccine called WOKVAC alongside standard chemotherapy and HER2-targeted drugs before surgery can boost the immune response and improve treatment outcomes for people with HER2-positive breast cancer. **You may be eligible if...** - You are 18 years or older - You have stage I–III HER2-positive breast cancer (confirmed by standard pathology tests) - You are planning to receive standard pre-surgery chemotherapy with trastuzumab and pertuzumab - You are in good physical condition (ECOG 0–1) - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You have already completed more than one round of pre-surgery chemotherapy (other than paclitaxel + trastuzumab + pertuzumab) - You are pregnant, planning to become pregnant, or breastfeeding - You have a serious immune condition or autoimmune disease - You have significant abnormalities in blood, liver, or kidney tests 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

BIOLOGICALpUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine

Given ID

DRUGPaclitaxel

Given via infusion

BIOLOGICALTrastuzumab

Given IV

BIOLOGICALPertuzumab

Given IV

DRUGDocetaxel

Given IV

DRUGCarboplatin

Given IV

PROCEDUREUltrasound Imaging

Undergo ultrasound imaging

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT04329065


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