A trial comparing 6 months and 12 months of trastuzumab (Herceptin) for early breast cancer (PERSEPHONE)

You can enter this trial if you

• Have breast cancer and are going to have chemotherapy as part of your treatment
• Have breast cancer that produces a large amount of HER2
• Are well enough to take part in the trial (performance status 0 or 1)
• Have satisfactory blood test results
• Are willing to use reliable contraception if there is any chance that you could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have breast cancer that has spread elsewhere in your body (metastatic breast cancer)
• Have already had trastuzumab 10 times or more
• Have had any other type of cancer, apart from non melanoma skin cancer, carcinoma in situ of the cervix or DCIS that have been successfully treated, or another cancer that was treated with surgery only, and has been in complete remission for at least 10 years
• Have had a heart attack in the last 6 months or have any other heart problem that is a cause for concern
• Have high blood pressure that is not controlled with medicine
• Have any other condition that could affect you taking part in this trial
• Are allergic to any of the products used to make trastuzumab
• Are pregnant or breastfeeding

This trial will recruit 4,000 women. It is a randomised trial. The people taking part will be put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group A will have trastuzumab for 12 months

Group B will have trastuzumab for 6 months

You will have the trastuzumab either at the same time as your chemotherapy or after your chemotherapy. This will depend on the type of chemotherapy you have and your hospital’s policy. If you have trastuzumab after your chemotherapy, it will start within 3 months of your last chemotherapy treatment.

You have trastuzumab through a drip into a vein. The first time you have it, this takes 90 minutes and you have to stay in hospital for at least 6 hours afterwards. If you don’t have any problems with the first treatment, you can have the others more quickly. They will take 30 minutes each.

The researchers will get a sample of the tissue that is removed when you have your surgery for breast cancer. And they will also ask you to give a blood sample on one occasion anytime before, during or after chemotherapy. They will study these samples to learn more about breast cancer.

The trial team will ask you to fill out a questionnaire before you start trastuzumab, then every 3 months for a year and every 6 months in the next year. The questionnaire will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study. 

You will see the doctors and have some tests before you start the trial treatment. The tests you may have include

• Physical examination
• Blood tests
• CT scan
• Chest X-ray
• Heart trace (ECG)
• Heart scan (MUGA or echocardiogram)

If you have trastuzumab at the same time as your chemotherapy, you will probably have the first dose on a different day to your first chemotherapy treatment. After that, you may be able to have both treatments on the same day, once every 3 weeks. But you might have to go to hospital on 2 separate days each time. This will depend on the policy at your hospital. After you finish chemotherapy, you will continue to go to the hospital every 3 weeks, until you finish your trastuzumab treatment.

If you have trastuzumab after your chemotherapy, you will have a hospital visit every 3 weeks for as long as you have treatment. If you are in group A, you will go another 18 times after you finish chemotherapy. If you are in group B, it will be 9 times.

You have a heart scan every 3 months while you are having trastuzumab. After you finish your treatment, you will see the trial doctors for follow up appointments

• Every 3 months for the first year
• Every 6 months in the second year
• Once a year after that

Common side effects of trastuzumab include

• Flu like symptoms
• Feeling sick
• Diarrhoea

You are most likely to have these side effects during the first or second treatment with trastuzumab.

Trastuzumab can cause heart problems in some people, which is why you have regular heart scans. If it does affect your heart, the doctors will stop the treatment and any problems will usually get better.

A small number of people have an allergic reaction when they have trastuzumab. The trial team will monitor you very closely and will treat any problems straight away.

There is more information about the side effects of trastuzumab and general side effects of chemotherapy on CancerHelp UK.

There is some more information about the PERSEPHONE trial on the Warwick Medical School website.