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NCT00003440 · ClinicalTrials.gov registry record · Phase 3

Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
580
Enrollment target

NCT00003440: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00003440 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 580 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003440, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
580 participants
Enrollment target

Study Summary

This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG paclitaxel
  • PROCEDURE quality-of-life assessment
  • BIOLOGICAL trastuzumab

Trial Details

FieldValue
Enrollment Target 580 participants
Start Date 1998-07
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00003440

The ClinicalTrials.gov registry entry for NCT00003440 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT00003440 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00003440 about?

NCT00003440 is a clinical study titled "Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic". This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumo...

What is the current status of trial NCT00003440?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 1998-07.

What interventions are being tested in trial NCT00003440?

The interventions under investigation include: laboratory biomarker analysis (OTHER), paclitaxel (DRUG), quality-of-life assessment (PROCEDURE), trastuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00003440?

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

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.