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NCT00820222 · ClinicalTrials.gov registry record · Phase 3
Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
NCT00820222: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00820222 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 540 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00820222, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
Study Summary
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
Primary Outcome
CNS relapse is defined as the appearance of \>=1 enhancing lesion measuring \>=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without s
Interventions
- DRUG trastuzumab
- DRUG capecitabine
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2009-04-14 |
| Est. Completion | 2018-03-22 |
| Phase | Phase 3 |
What the finished NCT00820222 record still lists
NCT00820222 is an interventional study that assigns participants to a tested intervention. The registered 540 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 (30% lower).
The record links to 0 conditions, and to 3 interventions - of which trastuzumab is the first listed.
NCT00820222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00820222 about?
NCT00820222 is a clinical study titled "Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer". This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
What is the current status of trial NCT00820222?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2009-04-14. Estimated completion is 2018-03-22.
What interventions are being tested in trial NCT00820222?
The interventions under investigation include: trastuzumab (DRUG), capecitabine (DRUG), lapatinib (DRUG).
Who is sponsoring clinical trial NCT00820222?
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 NCT00820222's enrollment target sits among peer trials
540 694th of 2000 higher than 1,301 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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