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COMPLETED Phase 1

Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

NCT01922921 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 31 participants
Start Date 2014-02-05
Est. Completion 2021-09-01
Phase Phase 1

Sponsor

University of Washington

987 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01922921

The ClinicalTrials.gov registry entry for NCT01922921 describes a study currently listed as completed. It is categorized as Phase 1, 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 31 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 Stage IV Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Placebo 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: NCT01922921 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01922921?

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 NCT01922921 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