Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

NCT00320385 ↗

Phase 3 Completed 296 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Timeline

Start: 2005-11
Primary completion: 2007-06
Completion: 2010-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Trastuzumab + Lapatinib vs Lapatinib; p = 0.008; Hazard Ratio (HR) 0.73 (95% CI 0.57 to 0.93); Log Rank NCT00320385 ↗

Publications

Background Wu Y, Amonkar MM, Sherrill BH, O'Shaughnessy J, Ellis C, Baselga J, Blackwell KL, Burstein HJ. Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer. Ann Oncol. 2011 Dec;22(12):2582-2590. doi: 10.1093/annonc/mdr014. Epub 2011 Mar 15.
Background Blackwell KL, Burstein HJ, Storniolo AM, Rugo HS, Sledge G, Aktan G, Ellis C, Florance A, Vukelja S, Bischoff J, Baselga J, O'Shaughnessy J. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J Clin Oncol. 2012 Jul 20;30(21):2585-92. doi: 10.1200/JCO.2011.35.6725. Epub 2012 Jun 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	Lapatinib	Small molecule	1500 mg	Oral
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous