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NCT00004038 · ClinicalTrials.gov registry record · Phase 1

Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00004038: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00004038 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00004038, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Combining chemotherapy with gene therapy may kill more tumor cells.

Interventions

  • DRUG chemotherapy
  • BIOLOGICAL Ad5CMV-p53 gene

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 1999-01
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00004038 record still lists

NCT00004038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 2 interventions - of which chemotherapy is the first listed.

NCT00004038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004038 about?

NCT00004038 is a clinical study titled "Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer". Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Combining chemotherapy with ge...

What is the current status of trial NCT00004038?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 1999-01.

What interventions are being tested in trial NCT00004038?

The interventions under investigation include: chemotherapy (DRUG), Ad5CMV-p53 gene (BIOLOGICAL).

Who is sponsoring clinical trial NCT00004038?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004038's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00004038, the US trial registry maintained by the National Library of Medicine. NCT00004038 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.