Lapatinib brain penetration PET study.

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  62401

• Contact name

  Charles Coombes

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd

• Eudract number

  2009-009884-76

• ISRCTN Number

  not issued

• Research summary

  Lapatinib is a molecule that stops the working of a protein called HER2 that is associated with cancer aggressiveness. However, it is not clear if lapatinib is able to reach the brain due to the protective effect of the 'blood-brain barrier', a physiologic mechanism that prevents the access of a number of drugs in to the brain. Consequently, the brain acts as a ??sanctuary site?? with isolated cancer recurrences in the brain despite good disease control in the rest of the body. This study aims to assess if lapatinib is able to cross an intact 'blood-brain barrier' to reach the brain. Additionally, this study will assess if access to brain is different in the presence of secondary cancer deposits when the 'blood-brain barrier' is impaired. In this study, we will perform positron emission tomography (PET) scans to trace the behaviour of lapatinib attached to a small amount of radioactivity in HER2 over expressing breast cancer patients with . We plan to study 5 patients with known secondary deposits in the brain from breast cancer and 5 patients without secondary deposits in the brain. This experimental design will provide a comprehensive picture on the behaviour of lapatinib in the presence of an intact and an impaired blood brain barrier. If lapatinib does intact cross an intact 'blood brain barrier', this will have implications in the treatment of cancer with similar molecules as this could potentially result in a reduction in the incidence of secondary brain deposits leading to improved survival and a better quality of life. In this study each patient will undergo 2 PET scans - the first with a very small amount of laptinib and the second with a therapeutic dose of lapatinib, thereby allowing us to find out if higher doses of lapatinib can overcome the blood-brain barrier.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/93

• Date of REC Opinion

  17 Mar 2011

• REC opinion

  Further Information Favourable Opinion