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NCT00435409 · ClinicalTrials.gov registry record · Phase 3
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
NCT00435409: Completed Phase 3 study, sponsored by Pfizer.
NCT00435409 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 442 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00435409, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
Study Summary
The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
Primary Outcome
Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.
Interventions
- DRUG Capecitabine
- DRUG Sunitinib + Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2007-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT00435409 record still lists
NCT00435409 is an interventional study that assigns participants to a tested intervention. The registered 442 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 (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00435409 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00435409 about?
NCT00435409 is a clinical study titled "A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer". The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
What is the current status of trial NCT00435409?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2007-02. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00435409?
The interventions under investigation include: Capecitabine (DRUG), Sunitinib + Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00435409?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00435409's enrollment target sits among peer trials
442 867th of 2000 higher than 1,134 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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