An Open-label Positron Emission Tomography Study to Investigate and Quantify Brain and Tumour Penetration of [11C]Lapatinib in Subjects With HER2-overexpressing Breast Cancer.
Lapatinib is an anti-cancer drug taken by mouth which inhibits the HER2 protein,
overexpressed in some breast tumours. It is not known whether lapatinib passes through the
blood-brain barrier, and, therefore, whether it can target secondary tumours in the brain.
This study will investigate whether lapatinib does indeed enter the brain.
Subjects with HER2-overexpressing breast cancer, with and without brain metastases, will
receive lapatinib tablets daily for 8 days. The subjects will also receive lapatinib with a
small amount of radioactivity attached on the first and last days of dosing to investigate
whether it is taken up by the brain, using positron emission tomography (PET) scans.
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Brain penetration of [11C]lapatinib
GSK Clinical Trials
United Kingdom: Medicines and Healthcare Products Regulatory Agency