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NCT00393783 · ClinicalTrials.gov registry record · Phase 1

Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity

A Phase 1 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

Active
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT00393783: Active Phase 1 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00393783 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 13 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00393783, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
13 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response. The immune system consists of different kinds of cells and substances which help fight against infections and inflammation in the body. These antibodies and T-cells are part of the immune system that may also help to fight against tumor cells. One way to make antibodies and stimulate T-cells is to inject the patient with a preparation which contains material that may stimulate the immune system. This process is called an immunization. We are trying to immunize the patient against HER2/neu. In order to participate in this trial, the tumor must have a large amount of HER2/neu on its surface. The injection that the patient will receive in this trial is a piece of DNA made in bacteria which contains the gene for rat HER2. DNA is material which contains the information needed to produce many substances in the body. The HER2 gene encodes for a protein known as HER2.

Conditions Studied

Breast Cancer

Interventions

  • BIOLOGICAL MAB HER 2 (HERCEPTIN)

Study Locations (1)

New York

  • Memorial Sloan Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2006-05
Est. Completion 2026-05
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00393783

The ClinicalTrials.gov registry entry for NCT00393783 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which MAB HER 2 (HERCEPTIN) is the first listed.

NCT00393783 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00393783 about?

NCT00393783 is a clinical study titled "Xenogeneic HER2/Neu DNA Immunization for Patients With Metastatic and High Risk Breast Cancer: A Phase I Study to Assess Safety and Immunogenicity". The purpose of this study is to evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response. The immune system consists of different kinds of cells and substances which help fight against infections and inflammation in the body. These antibodies and T-cells are part of ...

What is the current status of trial NCT00393783?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2006-05. Estimated completion is 2026-05.

What conditions does trial NCT00393783 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00393783?

The interventions under investigation include: MAB HER 2 (HERCEPTIN) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00393783?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00393783 being conducted?

This trial has 1 study location across New York. 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

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, the data changelog, or report a data error.