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NCT00263588 · ClinicalTrials.gov registry record · Phase 2
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 242
- Enrollment target
NCT00263588: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT00263588 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 242 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00263588, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 242 participants
- Enrollment target
Study Summary
Determine how safe and effective lapatinib is when used to treat 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. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.
Primary Outcome
Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population) Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of
Interventions
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2005-12-02 |
| Est. Completion | 2018-03-15 |
| Phase | Phase 2 |
What the finished NCT00263588 record still lists
NCT00263588 is an interventional study that assigns participants to a tested intervention. The registered 242 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 (82% higher).
The record links to 0 conditions, and to 1 intervention - of which lapatinib is the first listed.
NCT00263588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00263588 about?
NCT00263588 is a clinical study titled "Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer". Determine how safe and effective lapatinib is when used to treat 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. Lapatini...
What is the current status of trial NCT00263588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 242 participants. The study started on 2005-12-02. Estimated completion is 2018-03-15.
What interventions are being tested in trial NCT00263588?
The interventions under investigation include: lapatinib (DRUG).
Who is sponsoring clinical trial NCT00263588?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00263588's enrollment target sits among peer trials
242 237th of 2000 higher than 1,762 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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