A study looking at pertuzumab for HER2 positive breast cancer that has spread (PERUSE)

Cancer type:

Breast cancer
Secondary cancers

Status:

Results

Phase:

Phase 3

This study looked at pertuzumab (Perjeta) and trastuzumab (Herceptin) with a taxane chemotherapy drug. It was for people with breast cancer that was HER2 positive. Open a glossary item 

This study was open to women and men whose breast cancer had spread into surrounding tissue (locally advanced breast cancer). And to those whose cancer had spread to another part of their body (secondary breast cancer).

This study was open for people to join between 2012 and 2014. The team published the results in 2020.

More about this trial

When this study was done the treatment for breast cancer that has spread or come back and is HER2 positive was a combination of  trastuzumab and a taxane Open a glossary item chemotherapy drug. 

The taxane chemotherapy drug could be one of the following:

  • paclitaxel
  • nab-paclitaxel
  • docetaxel

This combination has helped people with HER2 positive advanced breast cancer live longer without their cancer getting worse. But researchers are always looking for ways to improve treatment.

Pertuzumab is a targeted cancer drug Open a glossary item called a monoclonal antibody Monoclonal antibodies seek out cancer cells by looking for a particular protein on them.

We knew from research that the combining pertuzumab, trastuzumab and docetaxel helps people with HER2 positive advanced breast cancer. 

The aims of this study were to find out:

  • more about the side effects of combining pertuzumab, trastuzumab with docetaxel, paclitaxel and nab paclitaxel 
  • how well these combination works

Summary of results

The trial team found that the combination of pertuzumab, trastuzumab and a taxane helped people with HER2 positive breast cancer that had spread. 

About this trial
This was an international phase 3 trial. Of the 1,436 people who were in the trial 1,429 had pertuzumab, trastuzumab and a taxane. During treatment some people swopped from one taxane to another. 

  • 775 people initially had docetaxel.
  • 589 people initially had paclitaxel.
  • 65 people initially had nab paclitaxel.

On average everyone had 24 cycles of treatment Open a glossary item of pembrolizumab and 6 cycles of treatment of taxane.

Results
To find out how well treatment worked the team were able to look at 1,199 people. They had an area of caner the team could measure at the start. Overall treatment helped 959 people. For:

  • 175 people there was no sign of their cancer (a complete response)
  • 784 people their cancer had shrunk (a partial response)
  • 180 people their cancer had stayed the same (stable disease)

Of the remaining 60 people, for:

  • 50 people their cancer had got worse (progressive disease)
  • 10 people the team couldn’t measure how well the treatment worked

The team also looked at the median Open a glossary item length of time people were without a sign of cancer. They found that overall was just over 20½ months (20.7). When they looked at the 3 taxanes separately the median length of time was:

  • just under 19½ months (19.4) for docetaxel
  • just over 23 months (23.2) for paclitaxel
  • just over 19 months (19.2) for nab paclitaxel

The team looked at the median length of time people lived after their treatment. They found there wasn’t much difference between the 3 taxanes. The median length of time was just under 5½ years (65 months). 

Side effects
Overall the most common side effects reported were:

  • diarrhoea
  • hair loss
  • feeling or being sick
  • tiredness (fatigue)
  • feeling weak
  • a skin rash
  • stiff joints

There were differences in the side effects reported for each taxane. 

  • Nerve damage (peripheral neuropathy) and nose bleeds were more common with both paclitaxel and nab paclitaxel than docetaxel.
  • A high temperature with a low white blood cell count (febrile neutropenia) and a sore, inflamed mouth was more common with docetaxel than with paclitaxel or nab-paclitaxel.

The reported number and type of very bad side effects was similar for all 3 taxanes. 

This is apart from febrile neutropenia and a general drop in white blood cells. These were the highest in people who had docetaxel. And were the lowest in people who had nab paclitaxel. 

The side effects that caused people to stop pertuzumab and trastuzumab were heart-related problems. This was most commonly a change in the measurements of how well the heart works.

The side effects that caused people to stop their taxane were:

  • nerve damage causing pins and needles, tingling and pain
  • tiredness 
  • diarrhoea

Conclusion
The team concluded that using other taxanes such as paclitaxel or nab paclitaxel instead of docetaxel was just as safe and helpful.  

This may give doctors more choices of treatments that are better tolerated for people with HER2 positive advanced breast cancer.

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) 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.

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 David Miles

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9440

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

Last reviewed:

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