A trial of fulvestrant with vistusertib or everolimus for advanced breast cancer (MANTA)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This trial compared fulvestrant on its own with fulvestrant alongside either vistusertib or everolimus. It was for people with breast cancer that had come back after treatment or spread to another part of the body, and was oestrogen receptor positive.

More about this trial

Breast cancer that has receptors for the female hormone oestrogen is called oestrogen receptor (ER) positive breast cancer. Doctors can treat ER positive breast cancer with hormone therapy such as fulvestrant (Faslodex). It stops the oestrogen getting to the cancer cells and this helps stop the cancer growing.

In this trial, researchers wanted to find out if having either everolimus (Afinitor) or vistusertib (AZD2014) with fulvestrant improves treatment.

Vistusertib and everolimus are both cancer growth blockers called mTOR inhibitors. They stop signals that cancer cells use to divide and grow.

When this trial was done vistusertib was a new drug. But doctors sometimes used everolimus as part of treatment for people with ER positive breast cancer.

The researchers wanted to compare fulvestrant on its own with:

fulvestrant and continuous vistusertib
fulvestrant and intermittent vistusertib
fulvestrant and everolimus

The main aim of this trial was to find out which treatment was best for ER positive breast cancer that has come back after treatment or spread to another part of the body.

Summary of results

This trial showed that fulvestrant and everolimus worked better than fulvestrant alone or fulvestrant and vistusertib.

The research team recruited patients between 2014 and 2016, and presented the results at a conference in 2017.

Results

This trial recruited more than 300 women with breast cancer that had come back after treatment or had spread to another part of the body. They all had oestrogen receptor (ER) positive cancer.

The women taking part were put into 1 of 4 groups at random:

66 had fulvestrant alone
101 had fulvestrant and vistusertib every day (continuous)
95 had fulvestrant and vistusertib for 2 days out of every 7 (intermittent)
64 had fulvestrant and everolimus

The research looked at how long it was before the cancer started to grow. They found it was:

4.6 months for those who had fulvestrant alone
7.5 months for those who had fulvestrant and continuous vistusertib
7.6 months for those who had fulvestrant and intermittent vistusertib
12.1 months for those who had fulvestrant and everolimus

They also looked at how many women’s breast cancer stopped growing or got smaller and found it was:

more than 2 out of 10 people (25%) who had fulvestrant alone
about 3 out of 10 people (30%) who had fulvestrant and vistusertib
just over 4 out of 10 people (41%) who had fulvestrant and everolimus

Side effects

Many of the women who took part had side effects, but some were mild or didn’t last too long.

The most common side effects for women who had vistusertib or everolimus included:

rash
sore mouth (stomatitis)
weakness (asthenia)
feeling or being sick
diarrhoea
loss of appetite

The group who had continuous vistusertib generally had more side effects that could be classed as severe. The most common more severe side effect in this group was a rash.

The women who had fulvestrant alone had fewer side effects than women in the other groups. And they didn’t have any that were classed as serious, they were all mild or moderate.

The side effects in this group included weakness, headache and feeling sick.

Conclusion

The research team concluded that fulvestrant and everolimus worked better than fulvestrant alone, or fulvestrant and vistusertib. And that there is no significant benefit of having vistusertib with fulvestrant.

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

) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.