A trial looking at chemotherapy and capivasertib for triple negative breast cancer that has come back or spread (PAKT)

A total of 140 people were put into a treatment group at random:

• 68 had paclitaxel and capivasertib 
• 70 had paclitaxel and a dummy drug 

2 people in the paclitaxel and capivasertib group didn’t have treatment. When these results were published, 6 people in each group were still having treatment. 

Everyone had treatment for as long as it was working and the side effects weren’t too bad. 

The team looked at the results. They looked at how long it was before the cancer started to grow again. This was about:

• 5.9 months for those who had paclitaxel and capivasertib
• 4.2 months for those who had paclitaxel and the dummy drug
   

PAKT trial diagram

They also looked at how long people lived. This was about:

• 19.1 months in the paclitaxel and capivasertib group
• 12.6 months in the paclitaxel and dummy drug group

PAKT trial diagram

Gene changes
The team looked at how well adding capivasertib worked for people who had certain gene changes (mutations ) in their cancer cells. These were:

• PIK3CA
• AKT1
• PTEN

The team found capivasertib worked a bit better in people who had these gene changes. This was compared to those who didn’t have the gene changes. 

Side effects
The team say the side effects were as expected.

Most people had at least 1 side effect from treatment. But some of these were mild or didn’t last long. 

Some people had more severe side effects. This was:

• 37 out of 68 people (54.4%) in the capivasertib and paclitaxel group 
• 18 out of 70 people (25.7%) in the paclitaxel and dummy drug group

People who had capivasertib and paclitaxel had more severe side effects. These included: 

• diarrhoea 
• tiredness (fatigue)
• skin rash
• infections 
• a drop in the number of neutrophils

The more severe side effects of paclitaxel chemotherapy and the dummy drug included:

• diarrhoea 
• infections 
• a drop in the number of neutrophils 

Conclusion
The trial team found that adding capivasertib to paclitaxel chemotherapy increased the length of time before the cancer started to grow again. It also increased the length of time people lived. The team say more research looking at capivasertib for triple negative breast cancer needs to be done. 

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.

Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial
P Schmid and others
Journal of Clinical Oncology, 2019. Volume 38, issue 5, pages 423-433

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 ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the links we list above is active and the article is free and available to view.