CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 580 enrolled
Drug / intervention
Paclitaxel +1 moredrug
Likely dose
Lapatinib (GW572016) in combination with PaclitaxelAI-extracted
Key inclusion· 6
  • ✓Able to swallow an oral medication
  • ✓Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  • ✓Adequate kidney and liver function
  • ✓Adequate bone marrow function
Key exclusion· 9
  • ✕Prior treatment regimens for advanced or metastatic breast cancer
  • ✕Pregnant or lactating
  • ✕Conditions that would affect the absorption of an oral drug
  • ✕Active infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00075270
NCT00075270Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Jan 9, 2004·Updated May 6, 2015

In Brief

A Phase 3 clinical trial evaluating Paclitaxel and GW572016 (Lapatinib) for Neoplasms, Breast. Completed, enrolled 580 participants across 177 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesArgentina, 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), United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 9, 2004
Enrollment StartJan 1, 2004
Primary CompletionOct 1, 2006
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.5 years ago

Interventions

Paclitaxeldrug

Active Comparator

GW572016 (Lapatinib)drug

Oral GW572016 Lapatinib