All about Persephone

As I mentioned last week, the team running the Persephone trial have been good enough to answer some questions about Herceptin and the trial. Here they are. Even though I’m done with Herceptin, i found this really interesting. I hope you do too.

*

-Why is Herceptin such a wonder drug?

Herceptin has proved to be a major advance as it helps to cure a certain type of aggressive breast cancer described as HER2 positive. This cancer is made of cells which contain HER2, a molecule involved in the rapid multiplication of cancer cells.

- In layman’s terms, what is the Persephone trial and how did it come about?

The PERSEPHONE trial is about finding the right dose of Herceptin for the patient. At the moment, Herceptin is given for a whole year based on evidence from an international trial comparing 12 months to nothing. A more recent trial has suggested that Herceptin might be just as effective if given for 6 months rather than 12.

- Why is the Persephone trial important?

PERSEPHONE is an important academic trial because it addresses the question of how long you need to take Herceptin for.

- Is it really a big issue if Herceptin is over-prescribed?

Yes, because Herceptin can cause damage to the heart. Some chemotherapy treatments can also do this. Patients who receive both treatments are therefore at a greater risk of experiencing some damage to their heart. Also, it means that patients may be experiencing the side-effects of treatment for longer than necessary instead of returning to normal life quicker without the inconvenience of prolonged treatment.

- When will the trial report?

The trial should report 2 years after it has recruited its 4000th patient. Obviously this depends on the speed of recruitment but we are currently on target to have reliable results reported in 2016.

- If it turns out that 12 months of Herceptin is better than 6 months of Herceptin, what will happen to everyone who only had 6 months of treatment?

This is very unlikely based on the results of previous trials. Duration trials throughout Europe have safety committees and trial steering committees who regularly monitor safety and efficacy.

There is only a very small risk that 12 months of Herceptin is better than 6 months. However, if it was the case, patients who received only 6 months will be follow-up more closely than the others.

If it is reported that 6 months is safer than 12 months then the patients randomised to the 12 month arm will be closely monitored in terms of cardiac toxicity.

- Where is the Persephone trial taking place?

PERSEPHONE is offered in 117 hospitals throughout the UK. Another 20 hospitals will be open soon.

- What’s involved with taking part in the trial, apart from the 6 or 12 months of Herceptin?

We’d also like you to complete a quality of life questionnaire at various stages of treatment. This will help to give us a clearer picture of the impact of Herceptin treatment on everyday life. Also, the research team will ask you if they can send a sample of your blood and some of your tissue taken at surgery to the Cambridge Research Institute where analysis will be conducted to get a better understanding of HER2 positive breast cancer and how Herceptin works.

- Can anyone join, or ask to join?

To join, you have to be HER2 positive and have received less than 6 months of Herceptin treatment.

- Are other, similar trials being conducted?

Similar trials are conducted all over Europe and in New Zealand. In total more than 13,000 patients are going to participate in Herceptin duration trials comparing 12 months with a lesser duration.

- Where can those affected by breast cancer find out about this and other trials?

If you are interested, please ask your oncologist or contact the clinical trials team at your hospital.

Also, a list of trials that operate in the UK is accessible here. and here.

The Persephone trial website provides more information and it’s here.