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NCT02157051 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer
A Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by University of Washington.
- Active
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02157051: Active Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by University of Washington.
NCT02157051 is a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 42 participants, below the 65-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02157051, a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine may target immunogenic proteins expressed in breast cancer stem cells which are the component of breast cancer that is resistant to chemotherapy and has the ability to spread. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells.
Primary Outcome
The type and grade of toxicities noted during the immunization regimen will be summarized. Adverse events noted by the investigator/designated clinical research staff will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical and/or laboratory parameters.
Conditions Studied
Interventions
- BIOLOGICAL CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine
- OTHER Laboratory Biomarker Analysis
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-06 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What the registry record for NCT02157051 still lists
NCT02157051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 65-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (35% lower).
The record links to 7 conditions, with Stage IV Breast Cancer 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.
NCT02157051 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT02157051 about?
NCT02157051 is a clinical study titled "Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer". This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine may target immunogenic pro...
What is the current status of trial NCT02157051?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2015-06. Estimated completion is 2026-09-01.
What conditions does trial NCT02157051 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer.
What interventions are being tested in trial NCT02157051?
The interventions under investigation include: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT02157051?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02157051 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02157051's enrollment target sits among peer trials
42 9th of 30 higher than 22 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Breast Cancer 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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