A trial using G-CSF to try to reduce the risk of infection in people having chemotherapy for breast cancer (SPROG)

Please note this trial is no longer recruiting patients.

This trial wants to find out if G-CSF can prevent infection in people having chemotherapy for breast cancer, so that they can continue on the same dose throughout treatment.

Breast cancer is often treated with chemotherapy. Some of the chemotherapy drugs used can cause a drop in the number of red blood cells, white blood cells and platelets (cells that help the blood to clot).

If there is a drop in the number of white blood cells, it means that patients are at an increased risk of getting an infection. To try and prevent that happening again, the next dose of chemotherapy is sometimes reduced. If the dose of chemotherapy has to be reduced, there is a concern that the treatment may be less effective.

G-CSF is growth factor that stimulates white blood cells to grow. Giving G-CSF after each dose of chemotherapy may prevent the white blood cell count falling so far. The aim of this trial is to reduce the risk of infection, and to give the full dose of chemotherapy each time.

Recruitment

Start 01/10/2002

End 30/03/2007

Phase

Phase 3

Who can enter

You can enter this trial if you

Have breast cancer
Are having chemotherapy alone, or radiotherapy at the same time as your chemotherapy is given
Have had a drop in white blood cells (and had an infection) because of chemotherapy you are having
Are 18 years old or over

You cannot enter this trial if you

Have had chemotherapy before (apart from the chemotherapy regime you are having at the moment)
Have any other cancer
Have breast cancer which has spread to another part of your body
Are having radiotherapy on the days inbetween your chemotherapy treatments
Have had G-CSF before

Trial design

This trial aims to recruit over 400 patients. It is a randomised trial. There are 2 groups. The people taking part will be put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have G-CSF as an injection into the skin. You will either have filgrastim once a day for 7 days after you finish each cycle of chemotherapy. Or you will have one dose of pegfilgrastrim 24 hours after you finish each cycle of chemotherapy.

If you are in group 2, you will not have G-CSF after your chemotherapy. If your white blood cell count drops after chemotherapy, you will have treatment according to hospital policy. In some cases, the doctors may decide to reduce the dose of chemotherapy you have.

Hospital visits

You will not need to go to the hospital for any extra visits as a result of being in this trial. You can be taught to give yourself the injections. Or a nurse or family member can give them to you at home.

Side effects

The most common side effect of G-CSF is mild bone pain. If this does happen, it is easily treated with mild pain killers, and goes away after the treatment is stopped.

All chemotherapy drugs have some side effects. There is more information about this in the breast cancer section of CancerHelp UK.