Actively Recruiting
Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer
Led by University of Washington · Updated on 2025-11-06
25
Participants Needed
1
Research Sites
277 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
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.
CONDITIONS
Official 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 receive neoadjuvant therapy with paclitaxel, trastuzumab, and pertuzumab or docetaxel, carboplatin, trastuzumab, and pertuzumab
- Prior neoadjuvant chemotherapy allowed 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/mm^3 within 4 weeks before starting treatment
- Lymphocyte count of at least 500/mm^3 within 4 weeks before starting treatment
- Absolute neutrophil count of at least 1500/uL within 4 weeks before starting treatment
- Platelet count of at least 75,000/uL within 4 weeks before starting treatment
- Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal, or less than 3.0 mg/dL for patients with Gilbert's syndrome within 4 weeks before treatment
- AST/ALT less than or equal to 3 times the institutional upper limit of normal within 4 weeks before treatment
- Creatinine less than or equal to 2.0 mg/dL or creatinine clearance above 30 ml/min within 4 weeks before treatment
- Left ventricular ejection fraction at or above the lower limit of normal within 3 months before treatment
- Female patients of child-bearing potential must use dual contraception methods and have a negative pregnancy test at screening
- Male patients must use effective barrier contraception if sexually active with female of child-bearing potential
- Effective contraception must be used during study and for 3 months after last vaccine
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Symptomatic restrictive or dilated cardiomyopathy
- Unstable angina within 4 months before enrollment
- New York Heart Association class III-IV heart failure on treatment
- Symptomatic pericardial effusion
- Uncontrolled autoimmune disease requiring active systemic treatment
- Known hypersensitivity to GM-CSF adjuvant or contraindications to GM-CSF
- Pregnant or breastfeeding
- Known HIV-positive status
- History of uncontrolled diabetes
- Current or past hepatitis B or C virus infection unless treated and cleared
- Major surgery within 4 weeks before starting study vaccine
- Current use of immunosuppressive agents or systemic corticosteroids within 30 days before study drug (topical or inhaled corticosteroids allowed)
- Enrollment in another clinical trial with experimental therapy or devices
- Receiving any other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here