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Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors

Brain Metastases Clinical Trial

Official title:
Lapatinib and Whole Brain Radiotherapy for Patients With Brain Metastases From Lung and Breast Tumors. A Phase II Study of the Hellenic Cooperative Oncology Group (HeCOG).

Clinical Trial Summary

This phase II open-label study will be performed to evaluate the response rate of brain metastases from lung and breast tumors under treatment with WBRT and lapatinib.

Clinical Trial Description

Patients with breast or lung cancer who have developed brain metastases will be treated with WBRT (30Gy in 10 fractions) and lapatinib 1250mg once daily, followed by lapatinib treatment 1500mg once daily for a total duration of 6 weeks. At the 6 weeks timepoint, radiological assessment with brain MRI will take place to evaluate the response of the patients. Subsequent to the 6 weeks treatment period with lapatinib, the patients may discontinue lapatinib as monotherapy and the physicians can proceed with any therapy, according to their discretion. The patients will be followed-up every 12 weeks for disease progression and survival. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01218529
Study type Interventional
Source Hellenic Cooperative Oncology Group
Contact
Status Completed
Phase Phase 2
Start date October 2010
Completion date December 2014
View Details
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