Brain Metastases In ErbB2-Positive Breast Cancer

Phase 2 Terminated 22 enrolled GlaxoSmithKline

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

Timeline

Start: 2007-05
Primary completion: 2009-01
Completion: 2010-02

Outcome

Outcome not reported

Stopped (Enrollment): “Lapatinib-topotecan arm enrollment closed early per protocol amendment 2. Then enrollment into remaining arm terminated due to operational issues.”

Publications

Background Lin NU, Eierman W, Greil R, Campone M, Kaufman B, Steplewski K, Lane SR, Zembryki D, Rubin SD, Winer EP. Randomized phase II study of lapatinib plus capecitabine or lapatinib plus topotecan for patients with HER2-positive breast cancer brain metastases. J Neurooncol. 2011 Dec;105(3):613-20. doi: 10.1007/s11060-011-0629-y. Epub 2011 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	2000 mg/m2	Oral
Subject	Lapatinib	Small molecule	1250 mg	Oral
Subject	Topotecan	Small molecule	3.2 mg/m2	Intravenous