The purpose of this study is to find out how much lapatinib can enter both normal brains and brains in which tumours secondary to breast cancer have developed.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Unlabelled, administered orally
Radiolabelled, administered intravenously
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom
Brain penetration of [11C]lapatinib
Time frame: 8 days
Brain tumour penetration of [11C]lapatinib
Time frame: 8 days
Safety as assessed by number of subjects with adverse events
Time frame: 16-19 days
[11C]lapatinib uptake in non-brain tumour sites
Time frame: 8 days
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