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STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
NCT05455658 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.
Conditions Studied
Interventions
- BIOLOGICAL CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
- BIOLOGICAL Sargramostim
Study Locations (3)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore
Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Wisconsin
- University of Wisconsin Carbone Cancer Center — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-11-17 |
| Est. Completion | 2028-07-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05455658
The ClinicalTrials.gov registry entry for NCT05455658 describes a study currently listed as active not 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 33 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 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions — of which CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine 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: NCT05455658 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Maryland, Washington, Wisconsin. 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 NCT05455658 about?
NCT05455658 is a clinical study titled "STEMVAC in Patients With Early Stage Triple Negative Breast Cancer". This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC...
What is the current status of trial NCT05455658?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2022-11-17. Estimated completion is 2028-07-16.
What conditions does trial NCT05455658 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIIB 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 NCT05455658?
The interventions under investigation include: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (BIOLOGICAL), Sargramostim (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05455658?
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 NCT05455658 being conducted?
This trial has 3 study locations across Maryland, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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