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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

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
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the registry record for NCT00393783 still lists

NCT00393783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for 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.

Where NCT00393783's enrollment target sits among peer trials

13 1161st of 1224 higher than 59 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00393783, the US trial registry maintained by the National Library of Medicine. NCT00393783 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.