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Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

NCT00263588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2019-12-12

Study results available
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Summary

Determine how safe and effective lapatinib is when used to treat 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. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

lapatinib

tyrosine kinase inhibitor

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-02
Primary Completion
2007-09-25
Completion
2018-03-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • India
  • Italy
  • Japan
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00263588 on ClinicalTrials.gov