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Brain Metastases In ErbB2-Positive Breast Cancer

NCT00437073 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-10-15

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-01-31
Completion
2010-02-28

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437073 on ClinicalTrials.gov