Actively Recruiting
A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy
Led by University of Washington · Updated on 2026-05-19
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the immune response and side effects of the WOKVAC vaccine combined with chemotherapy and HER2-targeted antibody therapy before surgery in patients with breast cancer. This phase II trial focuses on patients with stages I to III HER2-positive breast cancer, aiming to enhance the body's ability to attack tumor cells by using these treatments together. The study evaluates whether adding WOKVAC to standard therapies like paclitaxel, trastuzumab, and pertuzumab can improve tumor cell destruction before surgery. Participants receive the WOKVAC vaccine injected into the skin on day 13, repeated up to three times if the disease does not progress and side effects are manageable. Alongside, they receive chemotherapy drugs including paclitaxel infusions on days 1, 8, and 15 or a combination of docetaxel and carboplatin on day 1, plus trastuzumab and pertuzumab infusions on day 1. Chemotherapy and antibody treatments are typically given by the participant's oncologist following standard care. Treatment cycles can be repeated up to four times, with patients undergoing imaging scans and biopsies during the study. Throughout the trial, participants provide blood samples and undergo ultrasound or magnetic resonance imaging to monitor their response. Researchers measure immune cells in tumor tissue after treatment and track side effects for up to five years. After completing treatment, patients are followed annually for up to five years to observe long-term outcomes and safety. The total participation time varies depending on individual treatment and follow-up schedules.
CONDITIONS
Brief Title
Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years of age
- Clinical stage I-III HER2-positive breast cancer regardless of estrogen or progesterone receptor status
- Planning to undergo neoadjuvant therapy with paclitaxel, trastuzumab, and pertuzumab or docetaxel, carboplatin, trastuzumab, and pertuzumab
- Patients who received prior neoadjuvant chemotherapy may participate but limited to paclitaxel, trastuzumab, and pertuzumab during study
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- White blood cell count of at least 3000/mm3 within 4 weeks before starting treatment
- Lymphocyte count of at least 500/mm3 within 4 weeks before starting treatment
- Absolute neutrophil count of at least 1500/µL within 4 weeks before starting treatment
- Platelet count of at least 75,000/µL within 4 weeks before starting treatment
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal or less than 3.0 mg/dL for Gilbert's syndrome patients within 4 weeks before treatment
- AST/ALT less than or equal to 3 times institutional upper limit of normal within 4 weeks before treatment
- Creatinine less than or equal to 2.0 mg/dL or creatinine clearance greater than 30 ml/min within 4 weeks before treatment
- Left ventricular ejection fraction at or above institution's lower normal limit within 3 months before treatment
- Female patients of child-bearing potential must use dual contraception methods and have a negative pregnancy test at screening; males must use effective barrier contraception if sexually active with females of child-bearing potential
- Willingness and ability to sign informed consent
You will not qualify if you...
- Symptomatic restrictive cardiomyopathy
- Dilated cardiomyopathy
- Unstable angina within 4 months before enrollment
- New York Heart Association class III-IV heart failure on active treatment
- Symptomatic pericardial effusion
- Uncontrolled autoimmune disease requiring systemic treatment
- Known allergy to granulocyte-macrophage colony stimulating factor (GM-CSF) or contraindications to GM-CSF
- Pregnant or breastfeeding
- Known HIV-positive status
- History of uncontrolled diabetes
- Current or past hepatitis B or C infection unless treated and cleared
- Major surgery within 4 weeks before starting study vaccine
- Current use of immunosuppressive or systemic corticosteroids within 30 days before starting study drug (except supportive steroids for chemotherapy)
- Enrollment in another clinical trial involving experimental therapy or devices
- Receiving other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (4 cycles of 21 days each)
Participants receive WOKVAC vaccination intradermally on day 13 and it repeats for up to 3 cycles if no disease progression or unacceptable toxicity occurs. They also receive chemotherapy and HER2-targeted monoclonal antibody therapy through infusions on specific days, repeated for up to 4 cycles depending on response and tolerance. Imaging and biopsy procedures, along with blood sample collections, occur throughout this period to monitor progress.
Multiple visits for chemotherapy and vaccinations over up to 4 cycles
Duration - Up to 5 years
After completing study treatment, participants are followed up annually for up to 5 years to monitor safety and long-term outcomes.
Annual visits for up to 5 years
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Jennifer Childs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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