A study of atezolizumab for people with triple negative breast cancer that has spread

Cancer type:

Breast cancer
Secondary cancers

Status:

Results

Phase:

Phase 3

This study was for people whose cancer had spread locally and surgery wasn’t possible or it had spread elsewhere and who hadn’t had treatment. 

Triple negative breast cancers are cancers that don’t have receptors Open a glossary item for oestrogen, progesterone or Her2.

More about this trial

Chemotherapy is the main treatment for triple negative breast cancer that has spread. One chemotherapy drug they can have is nab-paclitaxel.

In this study doctors wanted to see if adding a targeted cancer drug called atezolizumab improved treatment.
 
Atezolizumab is a drug that uses your immune system to help fight the cancer. It works by affecting a substance called PD-L1. When cancer cells have a lot of PD-L1 on their surface, the immune system doesn’t work properly in getting rid of them.
 
Atezolizumab blocks the way PD-L1 works (the PD-L1 pathway) and so it could help your immune system to stop or shrink the cancer growth.
 
Cancers with large amounts of PD-L1 are called PD-L1 positive cancers.
 
The main aims of this study were to find how:
  • useful atezolizumab with chemotherapy was to treat triple negative breast cancer
  • safe this combination was

Summary of results

Atezolizumab with nab-paclitaxel increased the time people with triple negative breast cancer lived without a sign of the cancer coming back. 
 
This trial was open for people to join between 2015 and 2017.
 
These results were published in 2018.
 
About this trial
This was an international phase 3 trial
 
It was a randomised trial. The people taking part were put into 1 of 2 treatment groups. Neither they or their doctor chose which group they were in.
 
Of the 902 people who joined:
  • 451 had atezolizumab and nab-paclitaxel
  • 451 had a dummy drug (placebo Open a glossary item) and nab-paclitaxel

Results
After an average follow up of just over a year (12.9 months) the researchers looked at the length of time people were alive without their disease getting worse. They found it was:
  • just over 7 months (7.2) for those who had atezolizumab and nab-paclitaxel
  • 5½ months for those who had the dummy drug and nab-paclitaxel
They also looked at the average length of time people lived after treatment (average overall survival). They found that it was:
  • just over 21 months (21.3) for those who had atezolizumab and nab-paclitaxel 
  • just over 17½ months (17.6) for those who had the dummy drug and nab-paclitaxel

PD-L1 positive cancers
For people with PD-L1 positive triple negative breast cancers the team looked at them as a separate group.  
 
The average time they were alive without their disease getting worse:
  • 7½ months for those who had atezolizumab and nab-paclitaxel
  • 5 months for those who had the dummy drug and nab-paclitaxel
Their average overall survival was:
  • Just over 2 years (25 months) for those who had atezolizumab and nab-paclitaxel
  • 15½ months for those who had the dummy drug and nab-paclitaxel
Side effects
For just under 16 out of every 100 people (15.9%) side effects were the reason for stopping treatment with atezolizumab and nab-paclitaxel. 
 
For just over 8 out of every 100 people (8.2%) side effects were the reason for stopping treatment with the dummy drug and nab-paclitaxel. 
 
The most common side effects in both groups were:
  • hair loss
  • feeling or being sick 
  • cough
  • tingling, numbness and pain in the fingers and toes (peripheral neuropathy)
  • a drop in white blood cells
  • high temperature
  • too little thyroid hormone being made by the thyroid gland (hypothyroidism)
Conclusion
The team concluded that atezolizumab with nab-paclitaxel increased the time people with triple negative breast cancer lived without a sign of the cancer coming back or getting worse.
 
This trial has also shown that treatments like atezolizumab can work for people with triple negative breast cancer that has PD-L1. Knowing whether your triple negative breast cancer has PD-L1 should be an important consideration in deciding which treatment you might need. 
 
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

Professor Peter Schmid

Supported by

Roche
Experimental Cancer Medicine Centre (ECMC)

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

13835

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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