Enzastaurin in Combination of Capecitabine to Treat Breast Cancer

Phase 2 Terminated 86 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.

Timeline

Start: 2007-03
Primary completion: 2009-03
Completion: 2009-03

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy”

registry analysis (unspecified test); Capecitabine + Enzastaurin vs Capecitabine + Placebo; p = 0.237; Log Rank NCT00437294 ↗

paper Given the lack of PFS benefit, capecitabine plus enzastaurin is unsuitable as therapy for patients with recurrent/progressive MBC after prior anthracycline and taxane therapy. PMID 20814815 ↗

Publications

Clemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	enzastaurin	Small molecule	500 mg	Oral
Background	Capecitabine	Small molecule	1250 mg/m2	—