CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 369 enrolled
Drug / intervention
Lapatinib +3 moredrug
Likely dose
Lapatinib 1000 mgfrom 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/NCT01160211
NCT01160211Phase 3Completed
CompareCT.gov

A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

Novartis Pharmaceuticals·interventional·Posted Jul 12, 2010·Updated Mar 7, 2025

In Brief

A Phase 3 clinical trial evaluating Lapatinib, Trastuzumab, and 1 other intervention for Neoplasms, Breast. Completed, enrolled 369 participants across 110 sites in 29 countries.

Detailed Summary

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Breast
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2010
Enrollment StartMay 5, 2011
Primary CompletionMar 11, 2016
Study CompletionJun 6, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.0 years ago

Interventions

Lapatinibdrug

1000 mg by mouth once a day

Trastuzumabdrug

Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks)

Aromatase Inhibitordrug

Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily

Lapatinibdrug

1500 mg by mouth once daily