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NCT00437073 · ClinicalTrials.gov registry record · Phase 2
Brain Metastases In ErbB2-Positive Breast Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00437073: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT00437073 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 22 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
NCT00437073, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.
Primary Outcome
CNS OR is defined as the number of participants with either a complete response (CR) or partial response (PR) as assessed by volumetric analysis of brain magnetic resonance imaging (MRI) and Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete resolution of all evaluable and non-evaluable brain metastases; PR: =\>50% reduction in the volumetric sum of all evaluable brain metastases compared to baseline.
Interventions
- DRUG capecitabine
- DRUG topotecan
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
Why NCT00437073 stopped before completion
NCT00437073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 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 3 interventions - of which capecitabine is the first listed.
NCT00437073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00437073 about?
NCT00437073 is a clinical study titled "Brain Metastases In ErbB2-Positive Breast Cancer". This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatin...
What is the current status of trial NCT00437073?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2007-05. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00437073?
The interventions under investigation include: capecitabine (DRUG), topotecan (DRUG), lapatinib (DRUG).
Who is sponsoring clinical trial NCT00437073?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00437073's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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