Study on WOKVAC Vaccine, Chemotherapy, and HER2-Targeted Therapy Before Surgery for Breast Cancer Treatment

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04329065

Provider View

This clinical trial is exploring the effects of combining the WOKVAC vaccine with chemotherapy and HER2-targeted therapy before surgery in patients with breast cancer. The study aims to see how well this combination works and what side effects it might have.

Patient Parameters

Program Overview

This study is testing a new approach to treating breast cancer by using a vaccine called WOKVAC along with chemotherapy and HER2-targeted therapies (trastuzumab and pertuzumab) before surgery. The WOKVAC vaccine is designed to help the immune system recognize and attack cancer cells. Chemotherapy drugs like paclitaxel work by stopping cancer cells from growing and spreading. Trastuzumab and pertuzumab target specific proteins on cancer cells, blocking signals that tell the cells to grow. By combining these treatments before surgery, the study hopes to kill more cancer cells and improve outcomes for patients.

Description

In this study, patients will receive the WOKVAC vaccine through a small injection into the skin on day 13 of each treatment cycle. This treatment can be repeated for up to 3 cycles if the cancer does not progress and side effects are manageable. Patients will also receive chemotherapy with paclitaxel on days 1, 8, and 15, and the HER2-targeted therapies trastuzumab and pertuzumab on day 1. These treatments are typically given by the patient's own oncologist as part of standard care. The chemotherapy and HER2-targeted therapies can be repeated for up to 4 cycles, depending on the patient's response and tolerance. After completing the study treatment, patients will be monitored annually for up to 5 years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have stage I-III breast cancer that is HER2-positive, regardless of hormone receptor status, and plan to receive pre-surgery treatment with paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP).
  • Patients who have had previous pre-surgery chemotherapy can only receive paclitaxel, trastuzumab, and pertuzumab during the study.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood cell counts and organ function, including:
    • White blood cell count of at least 3000/mm^3.
    • Lymphocyte count of at least 500/mm^3.
    • Neutrophil count of at least 1500/uL.
    • Platelet count of at least 75,000/uL.
    • Total bilirubin within normal limits, except for patients with Gilbert's syndrome.
    • Liver enzymes (AST/ALT) within normal limits.
    • Creatinine within normal limits or creatinine clearance above 30 ml/min.
    • Heart function within normal limits.
  • Women of childbearing potential must use two forms of contraception and have a negative pregnancy test before starting the study. Men must use effective contraception if sexually active with a woman of childbearing potential.
  • Must understand and agree to sign a written informed consent document.

Exclusion Criteria

  • Have certain heart conditions, such as symptomatic heart disease or recent unstable angina.
  • Have uncontrolled autoimmune diseases requiring treatment.
  • Have an allergy to the GM-CSF adjuvant used in the vaccine.
  • Be pregnant or breastfeeding.
  • Be HIV-positive.
  • Have uncontrolled diabetes.
  • Have active or untreated hepatitis B or C.
  • Have had major surgery within the last 4 weeks.
  • Be using immunosuppressive medications or systemic corticosteroids.
  • Be participating in another clinical trial involving experimental treatments.
  • Be receiving other investigational drugs.

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