Trials / Completed
CompletedNCT00320385
Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer
A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination With Trastuzumab Versus Lapatinib Monotherapy in Subjects With HER2-positive Metastatic Breast Cancer Whose Disease Has Progressed on Trastuzumab-Containing Regimens
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 296 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lapatinib | oral lapatinib once daily |
| BIOLOGICAL | Trastuzumab | IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2007-06-01
- Completion
- 2010-10-01
- First posted
- 2006-05-03
- Last updated
- 2016-02-26
- Results posted
- 2011-11-30
Locations
145 sites across 13 countries: United States, Austria, Bulgaria, Canada, Croatia, Czechia, Finland, Germany, Greece, Italy, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00320385. Inclusion in this directory is not an endorsement.