NCT00437073

Brain Metastases In ErbB2-Positive Breast Cancer

Study EGF107671 - a Phase II Study of Lapatinib Plus Topotecan or Lapatinib Plus Capecitabine in the Treatment of Recurrent Brain Metastases From ErbB2-Positive Breast Cancer Following Cranial Radiotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	capecitabine	capecitabine 2000mg/m2/day orally, Days 1-14, every 21 days
DRUG	topotecan	topotecan intravenous (IV, in the vien) 3.2mg/m2 Days 1, 8 and 15; every 28 days
DRUG	lapatinib	lapatinib administered 1250mg once daily orally

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-01-01
• Completion: 2010-02-01
• First posted: 2007-02-19
• Last updated: 2015-10-15
• Results posted: 2012-10-15

Locations

44 sites across 11 countries: United States, Austria, Belgium, Canada, France, Germany, Greece, Israel, Italy, Spain, Sweden