Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Stage IV Breast Cancer Recurrent Breast Carcinoma HER2/Neu Positive

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

1,048 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (53% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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

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.

Explore more on PlainTrial

Stage IV Breast Cancer

All registered trials for this condition

Recurrent Breast Carcinoma

All registered trials for this condition

Washington

All trials with a study site in Washington

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.