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RECRUITING Phase 2

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

NCT04329065 · View on ClinicalTrials.gov ↗

Study Summary

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

  • DRUG Docetaxel
  • DRUG Paclitaxel
  • BIOLOGICAL Trastuzumab
  • BIOLOGICAL Pertuzumab
  • BIOLOGICAL pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2022-04-20
Est. Completion 2027-08-15
Phase Phase 2

Sponsor

University of Washington

987 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04329065

The ClinicalTrials.gov registry entry for NCT04329065 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 987 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04329065 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04329065 about?

NCT04329065 is a clinical study titled "Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer". 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 ...

What is the current status of trial NCT04329065?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2022-04-20. Estimated completion is 2027-08-15.

What conditions does trial NCT04329065 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04329065?

The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Trastuzumab (BIOLOGICAL), Pertuzumab (BIOLOGICAL), pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04329065?

This trial is sponsored by University of Washington, which has 987 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04329065 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial