About this trial

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 criteria

Qualifiers

Patients must be at least >= 18 years of age

Clinical stage I-III breast cancer, HER2+ (per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guideline update, 2018), regardless of estrogen receptor (ER)/ progesterone receptor (PR) status and planning to undergo neoadjuvant therapy with either paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)

Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration the study

Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Disqualifiers

Symptomatic restrictive cardiomyopathy

Dilated cardiomyopathy

Unstable angina within 4 months prior to enrollment

New York Heart Association functional class III-IV heart failure on active treatment

Trial design

Treatments tested in this trial

  • pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
  • Paclitaxel
  • Trastuzumab
  • Pertuzumab
  • Docetaxel
  • Carboplatin
  • Ultrasound Imaging
  • Biopsy Procedure
  • Biospecimen Collection

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

1
Fred Hutch/University of Washington Cancer Consortium98109, SeattleWashington, United States

Sponsors and collaborators

University of Washington

Lead sponsor

United States Department of Defense

Collaborator