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.
Additional locations may be listed on ClinicalTrials.gov for NCT04329065.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Kristin Marie Kauno
Phone: 206-543-9258
PRIMARY OBJECTIVE:
I. To evaluate whether concurrent HER2 monoclonal antibody therapy, chemotherapy, and pUMVC3-IGFBP2-HER2-IGF1R plasmid deoxyribonucleic acid (DNA) vaccine (WOKVAC) therapy can significantly increase T-bet+ CD4+ and CD8+ tumor infiltrating T cells (TIL) in the neoadjuvant setting.
SECONDARY OBJECTIVES:
I. To determine whether the addition of WOKVAC to neoadjuvant chemotherapy and HER2-targeted monoclonal antibody therapy is safe in HER2+ breast cancer.
II. To determine if the magnitude of vaccine induced antigen specific type 1 helper cell (Th1) immunity after neoadjuvant therapy is associated with pathologic response.
OUTLINE:
Patients receive WOKVAC intradermally (ID) on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel intravenously (IV) and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1 . The chemo and trastuzumab and pertuzumab will most likely be given by the patients own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up annually for up to 5 years from enrollment.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorWilliam R. Gwin
