A trial looking at cabazitaxel for HER 2 negative breast cancer that has spread to the brain (CiPHER)

Cancer type:

Breast cancer
Cancer spread to the brain
Secondary cancers

Status:

Results

Phase:

Phase 2

This trial looked at a chemotherapy drug called cabazitaxel for people with HER2 negative breast cancer that had spread to the brain.

It was open for people to join between 2015 and 2017, and the team analysed the results in 2019.

More about this trial

Some breast cancers have large amounts of a protein called HER2. They are called HER2 positive breast cancers. 

But some breast cancers have either none or very little HER2. They are called HER2 negative cancers. This trial was for people with HER2 negative breast cancer. 

Some treatments target the HER2 protein, so they are less useful for cancers that are HER2 negative. This trial looked at a chemotherapy drug called cabazitaxel as a possible treatment for people in this situation.

The main aim of the trial was to find out if cabazitaxel is a useful treatment for HER2 negative breast cancer that had spread to the brain.

Summary of results

The research team found it hard to find people to take part in this trial. So it is difficult to draw any firm conclusions from the results.

Trial design
This trial was for people with HER2 negative breast cancer that had spread to the brain and couldn’t be removed with surgery.

The people taking part were put into a treatment group at random. Two out of every 3 people had cabazitaxel. And one out of every 3 people had standard treatment. In the standard treatment group, the doctors decided which treatment was best. This depended on each person’s situation. 

Results
The research team hoped that about 100 people would join this trial. But they found it more difficult than they expected to find people who wanted to, or were able to, take part. So they decided to stop the trial earlier than planned. 

A total of 19 people joined the trial. They were put into a treatment group at random:

  • 13 had cabazitaxel
  • 6 had standard treatment

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

  • 2.8 months for those who had cabazitaxel
  • 6.5 months for those who had standard treatment

They also looked at how long people lived for, and found it was:

  • 4.8 months for those who had cabazitaxel
  • 8.2 months for those who had standard treatment

The research team cannot say for sure that the differences in these results are down to the different treatments. This is because of the small number of people who took part. The difference in results could be due to chance.

Side effects
10 out of 13 people (77%) who had cabazitaxel and 4 out of 6 people (67%) who had standard treatment had at least 1 serious side effect. 

Two people who had cabazitaxel stopped treatment because of the side effects they were having.

Conclusion
It is hard to draw any firm conclusions from this trial because of the small number of people who took part. But the results suggest cabazitaxel doesn’t help people with HER2 negative breast cancer that has spread to the brain live longer.

Where this information comes from    
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. The figures we quote above were provided by the research team. 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

Dr Zafar Malik

Supported by

Amgen
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool Cancer Trials Unit
Sanofi

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11562

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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