NCT00075270

Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	Paclitaxel	Active Comparator
DRUG	GW572016 (Lapatinib)	Oral GW572016 Lapatinib

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-10-01
• Completion: 2012-03-01
• First posted: 2004-01-09
• Last updated: 2015-05-06
• Results posted: 2014-03-31

Locations

177 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Germany, Hungary, Italy, Latvia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Turkey (Türkiye)