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NCT00337103 · ClinicalTrials.gov registry record · Phase 3
E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,276
- Enrollment target
NCT00337103: Completed Phase 3 study, sponsored by Eisai.
NCT00337103 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,276 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00337103, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,276 participants
- Enrollment target
Study Summary
The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.
Primary Outcome
OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 2) if the participant was lost to follow-up before data cutoff, the date they were last known to be al
Interventions
- DRUG Capecitabine
- DRUG Eribulin Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,276 participants |
| Start Date | 2006-09-20 |
| Est. Completion | 2017-12-11 |
| Phase | Phase 3 |
What the finished NCT00337103 record still lists
NCT00337103 is an interventional study that assigns participants to a tested intervention. Its 1,276 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00337103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00337103 about?
NCT00337103 is a clinical study titled "E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes". The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capeci...
What is the current status of trial NCT00337103?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,276 participants. The study started on 2006-09-20. Estimated completion is 2017-12-11.
What interventions are being tested in trial NCT00337103?
The interventions under investigation include: Capecitabine (DRUG), Eribulin Mesylate (DRUG).
Who is sponsoring clinical trial NCT00337103?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00337103's enrollment target sits among peer trials
1,276 200th of 2000 higher than 1,801 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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