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NCT01922921 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
A Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01922921: Completed Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by University of Washington.
NCT01922921 is a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that has completed, run by University of Washington. The registered enrollment target is 31 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01922921, a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy works better when given with or without polysaccharide-K in treating breast cancer.
Primary Outcome
Evaluated using physical examinations and clinical labs by type and grade of toxicities noted during treatment, There were graded per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events 4.0.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Pertuzumab
- BIOLOGICAL HER-2/neu Intracellular Domain Protein
- BIOLOGICAL Polysaccharide-K
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2014-02-05 |
| Est. Completion | 2021-09-01 |
| Phase | Phase 1 |
What the finished NCT01922921 record still lists
NCT01922921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (53% lower).
The record links to 3 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01922921 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01922921 about?
NCT01922921 is a clinical study titled "Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy". This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving HER2-targeted monoclonal antibody the...
What is the current status of trial NCT01922921?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2014-02-05. Estimated completion is 2021-09-01.
What conditions does trial NCT01922921 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, HER2/Neu Positive.
What interventions are being tested in trial NCT01922921?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Pertuzumab (BIOLOGICAL), HER-2/neu Intracellular Domain Protein (BIOLOGICAL), Polysaccharide-K (BIOLOGICAL).
Who is sponsoring clinical trial NCT01922921?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01922921 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
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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 NCT01922921's enrollment target sits among peer trials
31 13th of 30 higher than 16 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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