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RECRUITING
NCT04329065
PHASE2

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

Sponsor: University of Washington

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-04-20

Completion Date

2027-08-15

Last Updated

2025-11-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine

Given ID

DRUG

Paclitaxel

Given via infusion

BIOLOGICAL

Trastuzumab

Given IV

BIOLOGICAL

Pertuzumab

Given IV

DRUG

Docetaxel

Given IV

DRUG

Carboplatin

Given IV

PROCEDURE

Ultrasound Imaging

Undergo ultrasound imaging

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States