A trial of lapatinib or trastuzumab alongside capecitabine for breast cancer that has spread to the brain (LANTERN)

Cancer type:

Breast cancer
Cancer spread to the brain
Secondary cancers

Status:

Results

Phase:

Phase 2

This trial compared lapatinib and capecitabine with trastuzumab and capecitabine for people with breast cancer that had spread to the brain. 

It was for people:

  • who had HER2 Open a glossary item positive breast cancer 
  • after radiotherapy to the brain 

This trial was open for people to join between 2011 and 2013. The team published the results in 2020.

Cancer Research UK supported this trial. 

More about this trial

Some breast cancers produce a large amount of a protein called HER2. The HER2 protein makes cancer cells divide and grow. Drugs such as trastuzumab (Herceptin) block HER2 and can stop cancer cells growing.

You might have had capecitabine and trastuzumab when this trial was done. But doctors wanted to improve treatment. They looked at adding a drug called lapatinib to capecitabine.  Lapatinib is a type of targeted drug Open a glossary item called a cancer growth blocker. It stops the signals that cancer cells use to divide and grow.

In this trial, some people had trastuzumab and capecitabine. And some had lapatinib and capecitabine. 

The aims of the trial were to:

  • compare the 2 treatments to see which combination works best 
  • learn more about the side effects
     

Summary of results

This trial closed early as the trial team couldn’t find enough people to join. So it wasn’t possible to conclude that one treatment was better than the other. But the trial team have produced some information about the treatments.

Trial design
This was a phase 2 trial. The trial team had hoped to find 130 people to take part. But only 30 people joined. They were put into 1 of 2 groups at random:

  • 16 had lapatinib and capecitabine
  • 14 had trastuzumab and capecitabine

 

People had treatment for as long as it was working and the side effects weren’t too bad. 

Results
The trial team looked at how well treatment worked. To do this they looked at the number of people whose cancer got worse at 6 months. On average this was just over:

  • 4 out of 10 people (41%) who had lapatinib and capecitabine
  • 4 out of 10 people (41%) who had trastuzumab and capecitabine 

They also looked at the number of people living whose cancer hadn’t got worse. This is progression free survival. On average this was:

  • just over 4 out of 10 people (44%) who had lapatinib and capecitabine
  • 5 out of 10 people (50%) who had trastuzumab and capecitabine

Side effects
More people who had lapatinib and capecitabine had problems with:

  • diarrhoea
  • tiredness (fatigue)
  • feeling sick
  • numbness, tingling, redness or soreness on the palms of your hands or soles of your feet (hand foot syndrome)
  • sore mouth 
  • liver problems
  • heartburn (indigestion)
  • an increased risk of bleeding

More people who had trastuzumab and capecitabine had problems with:

  • headaches
  • tummy pain
  • a drop in the number of blood cells causing an increased risk of tiredness and breathlessness and an increased risk of infection 

Conclusion
The trial team found it was difficult to find enough people to join this trial. This made it hard for the trial team to draw firms conclusions about how well treatment worked. So they didn’t think it would be possible to look at these treatments in a larger trial for people with breast cancer spread to the brain.

They say that the trial suggests that capecitabine and trastuzumab is an acceptable treatment for this group of people. 

All trial results help doctors and researchers understand more about different cancers and the best way to treat them. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Prof David Dodwell

Supported by

Cancer Research UK
Clinical Trials Research Unit (CTRU)
University of Leeds
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
Leeds Teaching Hospitals NHS Trust
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUKE/10/046.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

6957

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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