A trial using buparlisib with trastuzumab for breast cancer that has spread

Cancer type:

Breast cancer

Cancer spread to the brain

Secondary cancers

Status:

Results

Phase:

Phase 1/2

This trial looked at buparlisib (BKM120) with trastuzumab for breast cancer.

It was for people who had HER2 positive breast cancer Open a glossary item :

that had spread to another part of the body (advanced) or into the nearby tissue (locally advanced)
and had got worse while having trastuzumab

The trial was open for people to join between 2011 and 2014. The team published the results in 2018.

More about this trial

Some breast cancers have large amounts of a protein called HER2 on the surface of the cells. These cancers are HER2 positive. They can be treated with a drug called trastuzumab which targets the HER2 protein.

Cells normally divide in an organised way. But in cancer cells, proteins that help to control cell growth can change and make the cells grow more quickly.

Buparlisib is a targeted drug Open a glossary item called a cancer growth blocker. It blocks a group of proteins called PIK3. These proteins help cancer cells to grow. Blocking the PI3K proteins may stop cancer cells from growing.

Researchers thought that combining buparlisib with trastuzumab may work better than trastuzumab alone. And that combining buparlisib with trastuzumab and capecitabine may work for people whose breast cancer has spread to their brain.

The aims of this trial were to find out:

how well the combination of buparlisib and trastuzumab works
how well the combination of buparlisib, trastuzumab and capecitabine works for breast cancer that has spread to the brain
more about the side effects

Summary of results

The team found that the combination of buparlisib and trastuzumab had a limited use for people with advanced or locally advanced HER2 positive breast cancer.

Of the 53 people who joined the trial, 50 people had both buparlisib and trastuzumab. These are the results of those 50 people.

Everyone continued with the treatment until there was a sign that their cancer was getting worse.

The trial team looked at how well the treatment worked. They found that for:

1 person (2%) there was no sign of their cancer (complete response)
8 people (4%) their cancer had shrunk (partial response)
20 people (40%) their cancer had stayed the same (stable disease)

9 people had secondary cancer in their brain. They had buparlisib, trastuzumab and capecitabine. The team found that, at first, secondary cancer in the brain shrank in all 9 people. In 7 people, their cancer started to grow again in the brain or elsewhere in the body during the trial.

Side effects
Due to side effects:

10 people (20%) stopped treatment
34 people (68%) had the dose of treatment reduced or took a short break from treatment

The most common side effects were:

diarrhoea
feeling and being sick
loss of appetite
changes to how the liver works
tiredness
skin rash
cough
high amount of sugar in the blood
weakness
sore mouth
headache
anxiety
depression

Conclusion
The team concluded that the side effects of buparlisib and trastuzumab were acceptable. But that it has a limited effect on people with HER2 breast cancer that had spread.

The team looked at how well buparlisib, trastuzumab and capecitabine worked for people with a secondary cancer in the brain. They concluded that it was not possible to report any results for this. This was due to the small number of people in this group.

This trial has added to our understanding of HER2 breast cancer and how to treat it.

More detailed information
There is more information about this research in the reference below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Phase II study of buparlisib (BKM120) and trastuzumab in patients with HER2+ locally advanced or metastatic breast cancer resistant to trastuzumab-based therapy
B. Pistilli and others
Breast Cancer Research Treatment, 2018. Volume 168, issue 2, pages 357-364

Where this information comes from

We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.