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NCT00096434 · ClinicalTrials.gov registry record · Phase 2
Sorafenib in Treating Patients With Metastatic Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00096434: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00096434 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096434, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
Primary Outcome
A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. A 90% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.
Interventions
- OTHER laboratory biomarker analysis
- DRUG sorafenib tosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2004-09 |
| Phase | Phase 2 |
What the finished NCT00096434 record still lists
NCT00096434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT00096434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00096434 about?
NCT00096434 is a clinical study titled "Sorafenib in Treating Patients With Metastatic Breast Cancer". This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
What is the current status of trial NCT00096434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2004-09.
What interventions are being tested in trial NCT00096434?
The interventions under investigation include: laboratory biomarker analysis (OTHER), sorafenib tosylate (DRUG).
Who is sponsoring clinical trial NCT00096434?
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 NCT00096434's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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