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NCT00320385 · ClinicalTrials.gov registry record · Phase 3
Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
NCT00320385: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00320385 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 296 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00320385, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
Study Summary
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.
Primary Outcome
PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.
Interventions
- BIOLOGICAL Trastuzumab
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2005-11 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00320385 record still lists
NCT00320385 is an interventional study that assigns participants to a tested intervention. The registered 296 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 (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT00320385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00320385 about?
NCT00320385 is a clinical study titled "Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer". This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.
What is the current status of trial NCT00320385?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2005-11. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00320385?
The interventions under investigation include: Trastuzumab (BIOLOGICAL), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00320385?
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 NCT00320385's enrollment target sits among peer trials
296 1164th of 2000 higher than 835 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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