NCT04329065 · University of Washington
Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer
What this study 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.
View original scientific description
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.
Interventions
BIOLOGICAL
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
Given ID
DRUG
Paclitaxel
Given via infusion
BIOLOGICAL
Trastuzumab
Given IV
BIOLOGICAL
Pertuzumab
Given IV
DRUG
Docetaxel
Given IV
DRUG
Carboplatin
Given IV
PROCEDURE
Ultrasound Imaging
Undergo ultrasound imaging
PROCEDURE
Biopsy Procedure
Undergo biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
Primary outcome measures
Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy
Time frame: Up to completion of surgical resection
Tumor tissue will be collected from prior diagnostic tumor biopsies as well as from an ultrasound guided core needle biopsy performed on day 13 of cycle 3. Tumor biopsies collected pre- and post- trial therapy will be processed and evaluated by immunohistochemistry for differences and changes in T cell content and T cell subtype. Specifically, will evaluate the differences in the presence of T-bet+ CD4+ and CD8+ T cells, a T cell subtype recently recognized to influence both the induced human epidermal growth factor receptor 2 (HER2)-specific cellular immunity and clinical outcomes. Changes in the tumor content of T-bet+ CD4+ and CD8+ T cells between the pre- and post-trial therapy time points will be evaluated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- White blood cell (WBC) \>= 3000/mm\^3 (within 4 weeks of initiating study treatment)
- Lymphocyte count \>= 500/mm\^3 (within 4 weeks of initiating study treatment)
- Absolute neutrophil count (ANC) \>= 1,500/ uL (within 4 weeks of initiating study treatment)
- Platelets \>= 75,000/ uL (within 4 weeks of initiating study treatment)
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL (within 4 weeks of initiating study treatment)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 4 weeks of initiating study treatment)
- Creatinine =\< 2.0 mg/dL or creatinine clearance \> 30 ml/min (within 4 weeks of initiating study treatment)
- Left ventricular ejection fraction (LVEF) \>= lower limit of normal for institution performing the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done within 3 months of initiating study treatment
- Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last vaccine
- Ability to understand and willingness to sign a written informed consent document
Exclusion criteria
- Patients with any of the following cardiac conditions:
- 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
- Symptomatic pericardial effusion
- Uncontrolled autoimmune disease requiring active systemic treatment
- Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF
- Pregnant or breast feeding
- Known human immunodeficiency virus (HIV)-positive
- History of uncontrolled diabetes
- Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
- Major surgery within the 4 weeks prior to initiation of study vaccine
- Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids =\< 30 days prior to starting study drug will be excluded \
- NOTE: Steroids given as supportive care for the neoadjuvant chemotherapy regimens is allowable per standard of care
- Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug
- Patients may not be receiving any other investigational agents
Where
- Seattle, Washington
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations