Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Phase 2 Completed 138 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Timeline

Start: 2004-06
Primary completion: 2008-03
Completion: 2008-03

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Lapatinib 1500 mg QD vs Lapatinib 500 mg BID; p = 0.691; Odds Ratio (OR) 0.8 (95% CI 0.3 to 1.9); Fisher Exact NCT00089999 ↗

registry analysis (superiority or other test); Lapatinib 1500 mg QD vs Lapatinib 500 mg BID; p = 0.443; Odds Ratio (OR) 0.7 (95% CI 0.3 to 1.6); Fisher Exact NCT00089999 ↗

Publications

Background Lipton A, Leitzel K, Ali SM, Carney W, Platek G, Steplewski K, Westlund R, Gagnon R, Martin AM, Maltzman J. Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy. Cancer. 2011 Nov 1;117(21):5013-20. doi: 10.1002/cncr.26101. Epub 2011 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	500 mg	Oral
Subject	Lapatinib	Small molecule	1500 mg	Oral