CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 163 enrolled
Drug / intervention
lapatinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00558103
NCT00558103Phase 2Completed
CompareCT.gov

A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib Versus Lapatinib Monotherapy in Patients With ErbB2 Over-expressing Inflammatory Breast Cancer

GlaxoSmithKline·interventional·Posted Nov 14, 2007·Updated Feb 4, 2013

In Brief

A Phase 2 clinical trial evaluating lapatinib and Pazopanib for Neoplasms, Breast. Completed, enrolled 163 participants across 126 sites in 28 countries.

Detailed Summary

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesAustralia, Belgium, Canada, Chile, China, Czechia, Egypt, France, Germany, Greece, Hong Kong, Israel, Italy, Morocco, Pakistan, Peru, Philippines, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2007
Enrollment StartDec 1, 2007
Primary CompletionMay 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.6 years ago

Interventions

lapatinibdrug

Oral administration

Pazopanibdrug

Oral administration