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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at whether women with early breast cancer can safely have trastuzumab (Herceptin) for 6 months instead of 12.

Women with early stage breast cancer may have chemotherapy as part of their treatment. They may have this before or after surgery. If their breast cancer produces high levels of a protein called HER2, they will also have trastuzumab. This helps to reduce the risk of the cancer coming back.

Women usually have trastuzumab for 12 months. But doctors are not sure if treatment needs to be this long. It may work just as well if you have it for a shorter period of time. Also, having trastuzumab for less time may reduce the risk of side effects, such as damage to the heart.

In this trial, the researchers will compare 12 months of trastuzumab with 6 months. Everybody taking part will have chemotherapy as well. The aims of the trial are to

Find out if 6 months of treatment works as well as 12 months
See if having treatment for a shorter time can help lower the risk of damage to the heart

Taking part in this trial will not delay or affect any other treatment you have, such as radiotherapy or hormone therapy.

Who can enter

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 have chemotherapy and trastuzumab
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 more than 9 times
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 a heart problem that is a cause for concern, or any other medical condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

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 either through a drip into a vein or as an injection under the skin (subcutaneous injection).

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.

Hospital visits

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 4 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

Side effects

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.

We have more information about the side effects of trastuzumab and general side effects of chemotherapy.

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

Recruitment start:

04/10/2007

Recruitment end:

31/07/2015

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Dr Helena Earl

Supported by

Addenbrookes Hospital
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University of Cambridge
Warwick Medical School Clinical Trials Unit

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

Freephone 0808 800 4040

Email