The trial team found that buparlisib didn’t improve treatment when added to paclitaxel.
The trial was open for women to join between 2012 and 2014. The researchers published the results in November 2016.
About this trial
Women were put into treatment groups at
random.
416 women took part and:
- 207 had paclitaxel and buparlisib
- 209 had paclitaxel and a dummy drug (placebo
)
Before treatment, the doctors checked tumour samples the women had taken. They wanted to find out who had changes to the PI3K gene in their breast cancer cells. This is called molecular testing.
They found:
- 269 didn’t have a gene change in the PI3K gene
- 147 had a gene change (mutation
) in the PI3K gene
Results
The researchers looked at how long the women lived before the cancer started to grow again. This is called progression free survival. They didn’t find any difference:
- between the 2 treatment groups
- in how well treatment worked in women who had a PI3K gene change in their breast cancer cells compared to those who didn’t
So, adding buparlisib was no more help than standard paclitaxel.
Because of these findings, the trial closed earlier than planned and didn’t move into phase 3.
Side effects
The most common side effects of paclitaxel and buparlisib included:
- diarrhoea
- hair loss
- skin rash
- feeling sick
- high levels of sugar in the bloods
Conclusion
The trial team found that adding buparlisib to paclitaxel wasn’t better than paclitaxel for women with advanced HER2 negative breast cancer. But all trial results help doctors and researchers understand more about different cancers and the best way to treat them.
Where do these results come 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.