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NCT00791037 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

A Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
1
Study location

NCT00791037 is a Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer that has completed, run by University of Washington. The registered enrollment target is 23 participants, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00791037, a Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)

Conditions Studied

HER2-positive Breast Cancer Stage IV Breast Cancer Recurrent Breast Cancer Male Breast Cancer

Interventions

  • DRUG cyclophosphamide
  • PROCEDURE leukapheresis
  • BIOLOGICAL sargramostim
  • BIOLOGICAL HER-2/neu peptide vaccine
  • BIOLOGICAL ex vivo-expanded HER2-specific T cells

Study Locations (1)

Washington

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2008-10
Est. Completion 2014-12
Phase Phase 1

Sponsor

University of Washington

1,048 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00791037

The ClinicalTrials.gov registry entry for NCT00791037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (90% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT00791037 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT00791037 about?

NCT00791037 is a clinical study titled "Vaccine Therapy in Treating Patients With Stage IV Breast Cancer". This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cel...

What is the current status of trial NCT00791037?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2008-10. Estimated completion is 2014-12.

What conditions does trial NCT00791037 study?

This clinical trial studies the following conditions: HER2-positive Breast Cancer, Stage IV Breast Cancer, Recurrent Breast Cancer, Male Breast Cancer.

What interventions are being tested in trial NCT00791037?

The interventions under investigation include: cyclophosphamide (DRUG), leukapheresis (PROCEDURE), sargramostim (BIOLOGICAL), HER-2/neu peptide vaccine (BIOLOGICAL), ex vivo-expanded HER2-specific T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT00791037?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00791037 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.