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WOKVAC Vaccine with Chemotherapy and HER2-Targeted Therapy for Breast Cancer

This study is looking at how a vaccine called WOKVAC works with standard chemotherapy (like paclitaxel or docetaxel) and HER2-targeted therapies (trastuzumab and pertuzumab) before surgery for breast cancer. WOKVAC is designed to help your body's immune system fight cancer cells. Trastuzumab and pertuzumab are targeted therapies that attach to specific proteins (HER2 receptors) on cancer cells. This study aims to see how these treatments together affect your immune system, specifically by counting certain immune cells (T-cells) in your tumor. You may be able to join if you are at least 18 years old and have Stage I, II, or III HER2-positive breast cancer. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 25 participants.
What's involved
You would receive WOKVAC injections, chemotherapy infusions, and trastuzumab and pertuzumab infusions over several cycles. You will also have ultrasound or MRI scans, biopsies, and blood draws throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed annually for up to 5 years from when you joined the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04329065

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Washington
~25 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA VaccinePaclitaxelTrastuzumabPertuzumabDocetaxelCarboplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy
Measured over Up to completion of surgical resection

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • William Gwin · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Jennifer Childs
[email protected]
206-616-2305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapyUp 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.