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NCT05455658 · ClinicalTrials.gov registry record · Phase 2
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by University of Washington.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 3
- Study locations
NCT05455658: Active Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by University of Washington.
NCT05455658 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 33 participants, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05455658, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Defined by the incidence of development of the Th1 (IFN-gamma \[g\]) antigen specific immune response against STEMVAC antigens using enzyme-linked immunosorbent spot assay (ELISPOT).
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 |
What the registry record for NCT05455658 still lists
NCT05455658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 304-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (89% lower).
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.
NCT05455658 reports a single indexed study location in Maryland, Washington, Wisconsin.
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.
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).
Who is sponsoring clinical trial NCT05455658?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05455658's enrollment target sits among peer trials
33 62nd of 84 higher than 23 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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