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

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

lantern.png

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 ) 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.