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NCT00374322 · ClinicalTrials.gov registry record · Phase 3
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,166
- Enrollment target
NCT00374322: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00374322 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,166 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (310% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00374322, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,166 participants
- Enrollment target
Study Summary
This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.
Primary Outcome
DFS=interval between the date of randomization and the date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause. The date of the event is the earliest date of the occurrence of any of the following: local recurrence (LR) following mastectomy; LR in ipsilateral breast following lumpectomy; regional recurrence; distant recurrence; contralateral breast cancer, including ductal carcinoma in situ; other second primary cancer (excluding squamous
Interventions
- OTHER placebo
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,166 participants |
| Start Date | 2006-08 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT00374322 record still lists
NCT00374322 is an interventional study that assigns participants to a tested intervention. Its 3,166 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (310% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00374322 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00374322 about?
NCT00374322 is a clinical study titled "Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer". This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radi...
What is the current status of trial NCT00374322?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,166 participants. The study started on 2006-08. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00374322?
The interventions under investigation include: placebo (OTHER), lapatinib (DRUG).
Who is sponsoring clinical trial NCT00374322?
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 NCT00374322's enrollment target sits among peer trials
3,166 75th of 2000 higher than 1,926 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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