A trial looking at ovarian protection for premenopausal women having chemotherapy for breast cancer (OPTION)

Who can enter

You can enter this trial if you

• You have stage 1, 2 or 3 breast cancer
• Are due to have chemotherapy
• Have not been through the menopause

You cannot enter this trial if you

• Have stage 4 breast cancer that has spread to another part of your body
• Have had chemotherapy before
• Have had any other cancer in the past, apart from non melanoma skin cancer or carcinoma in situ of the cervix
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 250 women into 2 groups. The women taking part will be put into treatment groups 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 chemotherapy alone. The drugs you have will depend on your individual situation. Your doctor will talk to you about your treatment in more detail. You will have chemotherapy for between 4 and 6 months altogether.

If you are in group 2 you will have chemotherapy for about 4 to 6 months. You will also have goserelin (Zoladex) injections once every 4 weeks while you are having chemotherapy.

You will fill out a questionnaire before you start treatment and for up to 5 years afterwards. This will ask you how you have been feeling and about any side effects you have had. It is called a Quality of Life questionnaire.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. These include

• Blood tests
• Chest X-ray
• Heart trace (ECG)
• Physical examination

You may also have a bone scan to check your bone density.

You will go to the hospital every 3 or 4 weeks for chemotherapy. Exactly how often you have treatment will depend on the combination of drugs your doctor decides is best for you. You are likely to have chemotherapy for between 4 and 6 months altogether.

If you are in group 2 you will have goserelin as an injection just under the skin once a month for as long as you have chemotherapy. This can be a bit sore, so you will have a local anaesthetic to numb the skin first.

After treatment you will see the doctors every 3 months for a year, every 6 months for another year, and then every year for 3 years.

Side effects

Goserelin stops the ovaries working, so you will have some menopausal symptoms if you are in group 2. These include

• Hot flushes
• Mood changes

There is more information about goserelin (Zoladex) and on coping with menopausal symptoms on CancerHelp UK.

The side effects of chemotherapy will depend on the drugs you have. But the most common side effects of chemotherapy for breast cancer are

• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and shortness of breath
• Feeling or being sick
• Hair thinning or hair loss

There is information about the side effects of specific chemotherapy drugs on CancerHelp UK.