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NCT00246571 · ClinicalTrials.gov registry record · Phase 2
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
NCT00246571: Completed Phase 2 study, sponsored by Pfizer.
NCT00246571 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 217 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00246571, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
Study Summary
The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
Primary Outcome
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Interventions
- DRUG Chemotherapy
- DRUG SU011248
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00246571 record still lists
NCT00246571 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Chemotherapy is the first listed.
NCT00246571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00246571 about?
NCT00246571 is a clinical study titled "Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer". The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.
What is the current status of trial NCT00246571?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2006-01. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00246571?
The interventions under investigation include: Chemotherapy (DRUG), SU011248 (DRUG).
Who is sponsoring clinical trial NCT00246571?
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 NCT00246571's enrollment target sits among peer trials
217 286th of 2000 higher than 1,715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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