CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8,381 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/NCT00490139
NCT00490139Phase 3Completed
CompareCT.gov

A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

Novartis Pharmaceuticals·interventional·Posted Jun 22, 2007·Updated Mar 21, 2025

In Brief

A Phase 3 clinical trial evaluating Lapatinib and Trastuzumab for Neoplasms, Breast. Completed, enrolled 8,381 participants across 924 sites in 44 countries.

Detailed Summary

This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone, compared to Trastuzumab alone in the adjuvant treatment of Human Epidermal Growth Factor Receptor 2 (HER2) positive early breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States
CollaboratorsNorth Central Cancer Treatment Group, National Cancer Institute (NCI), Breast International Group, Canadian Cancer Trials Group

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 22, 2007
Enrollment StartMay 16, 2007
Primary CompletionDec 6, 2013
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 19.0 years ago

Interventions

Lapatinibdrug

Small molecule inhibitor

Trastuzumabbiological

Antibody