A trial to see if radiotherapy can prevent breast cancer spreading to the brain in women treated with Herceptin (HER PCI)

Please note this trial is no longer recruiting patients.

This trial is trying to find out if radiotherapy to the brain helps to prevent breast cancer spreading to the brain (brain metastases). It is for women who are due to have Herceptin (trastuzumab) for breast cancer that is locally advanced or has spread.

You usually have chemotherapy for breast cancer that has spread. Women who are HER2 positive may also have a drug called Herceptin. Herceptin is a monoclonal antibody, a type of biological therapy.

Doctors know that if breast cancer spreads it can sometimes spread to the brain. Herceptin and chemotherapy treat most of the body as they travel in the bloodstream. But they cannot treat cancer cells that have spread to the brain because they cannot cross the ‘blood brain barrier’.

Radiotherapy to help prevent cancer spreading to the brain is called prophylactic (pronounced prof-ill-ac-tik) cranial irradiation (PCI). Doctors do not know yet if PCI will help stop breast cancer spreading to the brain. All treatments have side effects, so it is important that women don’t have treatment they do not need.

The aim of this trial is to see if radiotherapy to the brain can reduce the risk of breast cancer spreading there. The research team will also look at side effects and the women’s quality of life.

Recruitment

Start 02/03/2007

End 30/04/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Are a woman with breast cancer that is locally advanced or has spread to another part of your body (metastasised)
Have breast cancer that is strongly HER2 positive and you are due to have Herceptin treatment
Are well enough to take part (performance status 0,1 or 2)
Are at least 18 years old

You cannot enter this trial if you

Have breast cancer that has spread to the brain (brain metastases)
Have already had radiotherapy to the brain
Have had Herceptin before for breast cancer that is locally advanced or has spread
Have had surgery to the brain
Have a history of other conditions affecting the brain or nervous system, or have had fits (seizures) in the past

Trial design

This is a phase 3 trial and will recruit 390 patients. The trial is randomised. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part in the trial will have 6 weeks of Herceptin. This will either be on its own or with chemotherapy. Your doctor will choose the most suitable chemotherapy drugs for you.

Group 2 will then have 10 treatments (fractions) of radiotherapy to the brain.

The research team will ask you to fill out two questionnaires about how you are feeling during this trial. These are called ‘quality of life’ questionnaires. They will also ask you some questions to assess your memory and your level of anxiety. You fill them out before you start treatment, after the Herceptin and then every 8 weeks for 9 months.

Hospital visits

You will have a CT scan or MRI of the brain. This will happen within 6 weeks of starting treatment with Herceptin.

If you are in group 1 you won’t have any extra trips to the hospital.

If you are in group 2 you will go the hospital every day (Monday to Friday) for 2 weeks for radiotherapy. This will start after you have finished your six weeks of Herceptin treatment. Before you start radiotherapy, you will receive an appointment for planning the radiotherapy. This is to work out how much radiation you should receive and the exact area to be treated.

After you finish your treatment you will see the trial doctors every two months for at least a year.