Trials / Completed
CompletedNCT00374322
Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer
A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3,166 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lapatinib | Lapatinib 1500 mg (6 tablets) daily for 12 months |
| OTHER | placebo | 6 tablets daily for 12 months |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2011-09-01
- Completion
- 2013-07-01
- First posted
- 2006-09-11
- Last updated
- 2014-08-18
- Results posted
- 2014-08-18
Locations
439 sites across 33 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, New Zealand, Peru, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00374322. Inclusion in this directory is not an endorsement.