A study to find out how much lapatinib reaches breast cancer that has spread to the brain

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer
Cancer spread to the brain
Secondary cancers

Status:

Closed

Phase:

Other

This study is trying to find out how much lapatinib (Tyverb) gets to breast cancer that has spread (secondary breast cancer) to the brain. This study is for women whose breast cancer is HER2 positive. This means the breast cancer cells have tested positive for a protein called HER2.

Doctors often treat HER2 positive breast cancer with trastuzumab (Herceptin). However, trastuzumab is not known to get through to the brain. It may not be able to get past a membrane, called the blood brain barrier, which protects the brain

Lapatinib is a type of drug called a tyrosine kinase inhibitor (TKI). TKIs block tyrosine kinase which is a chemical messenger that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

Some research has suggested that TKIs may be able to get through the blood brain barrier and into the brain. The study team want to find out if lapatinib does this and the conditions of when and how lapatinib enters the brain.

To do this, the study team will compare the brain scans of women who are taking lapatinib and have secondary breast cancer in the brain with women who are taking lapatinib and don’t have secondary breast cancer in the brain.

The aims of this study are to find out how much lapatinib gets into secondary breast cancer in the brain and into normal brain tissue.  

Who can enter

You may be able to enter this trial if you are a woman and you

  • Have breast cancer that has spread to another part of the body (stage 4) and  is HER2 positive
  • Agree to have a needle put into an artery (blood vessel) in your wrist during the scan  
  • Are well enough to be up and about for at least half the day (performance status 0, 1, 2)
  • Have satisfactory blood test results
  • Are able to lie still on your back for up to 2 hours
  • Are willing to use reliable contraception if there is any chance you could become pregnant
  • Are at least 18 years old

If you have cancer that has spread to your brain, you must have 1 area that is at least 1 cm in size.

You cannot enter this trial if you

  • Have had surgery to remove the cancer in your brain
  • Have had radiotherapy to your brain less than 4 weeks before taking part in this study
  • Need to have chemotherapy, radiotherapy, surgery, immunotherapy or another biological therapy, apart from lapatinib, to treat your breast cancer
  • Have had another anti cancer treatment in the last month
  • Have cancer in the tissue covering the brain or spinal cord
  • Have a condition that can affect your brain, for example epilepsy, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, memory loss or a mental condition (psychiatric problem)
  • Are diabetic and need insulin to control your diabetes
  • Have problems with your heart, for example heart pain (angina), the rhythm of your heart beat or heart failure, that could affect you taking part in this study
  • Are HIV, hepatitis B or hepatitis C positive
  • Are known to misuse alcohol or drugs
  • Have any condition where your body cannot properly use the food you eat or medication you take, for example ulcerative colitis or diarrhoea
  • Have had trastuzumab (Herceptin) in the last 6 weeks
  • Have had another experimental treatment in the last month
  • Are known to be sensitive to anything in lapatinib or similar drugs
  • Are taking medications that could affect the way lapatinib works in the body – your doctor can advise about this
  • Are not able to have MRI scans (for example you a have a pacemaker or metal in your body, or cannot cope with being in small spaces)
  • Have another medical condition that could affect you taking part in this study
  • Are pregnant or breastfeeding

Trial design

This study will recruit 5 women who have secondary breast cancer in the brain and 5 women who don’t. Everyone taking part in this study will have lapatinib. 

You have 2 PET scans at Imanova Limited at the Hammersmith Hospital, London. At both scans the researchers will put 2 fine tubes (cannula) into the vein in your arms. One tube is to take blood from and the other is to inject a tiny amount of radioactive liquid lapatinib. The researchers will give you information about how to look after your arm when they take the cannula out.  

During the PET scan you must lie still on your back while the researchers take a scan of your head. This will take about an hour and half to 2 hours. After the first scan you will need to rest for an hour before going home.  

The researchers will give you a diary card to take home. You use it to fill in the times you take your lapatinib at home. You need to bring the diary with you when you come for the second PET scan.  

On the day of the second scan you need to arrive about 3 to 4 hours before the scan. And stay for 2 hours after to rest.  

If you agree, the researchers would also like to take a scan of another part of your body where the cancer is. This will take about 10 minutes.  

Hospital visits

You will see the doctor before taking part in this study and have some tests. These include

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace – ECG
  • Heart scan – ECHO
  • MRI scan
  • Testing to see if your blood vessel (artery) to your hand is large enough - Allen’s test

You have your first PET scan on the same day as you start taking lapatinib. You have the second PET scan 7 days after the first one.  

You see the doctor about 7 to 13 days after the 2nd PET scan for a physical examination and blood tests.  

The study team will arrange your travel to and from the hospital or refund your travel expenses.

Side effects

The most common side effects of lapatinib include

We have more information about lapatinib in our cancer drugs section.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Charles Coombes

Supported by

Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8040

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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