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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Multivariate logistic regression will be used to relate patient characteristics and pretreatment clinical variables with tumor response (complete or partial). Interim analyses will use a chi square statistic to compare response incidence by treatment arm with two-sided bounds constructed from the O'Brien-Fleming approach
Interventions
- OTHER laboratory biomarker analysis
- DRUG paclitaxel
- PROCEDURE quality-of-life assessment
- BIOLOGICAL trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 1998-07 |
| Phase | Phase 3 |
What the finished NCT00003440 record still lists
NCT00003440 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00003440 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003440's enrollment target sits among peer trials
580 656th of 2000 higher than 1,342 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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