A trial comparing radiotherapy and surgery for women with breast cancer which has spread to their lymph nodes (Amaros)

Who can enter

You can enter this trial if

• You have a single breast cancer lump that is more than 5mm and less than 50 mm across, OR you have more than one lump in the same area of your breast - your doctor can tell you more about this (you may be able to take part if you have cancer in each breast)
• The doctors did not find any enlarged lymph nodes under your arms when they examined you
• You are well enough to have any of the trial treatments

You cannot enter this trial if you

• Have stage 4 breast cancer that has spread to another part of your body (metastasised)
• Have in situ breast cancer (DCIS or LCIS)
• Have had previous surgery or radiotherapy to the area under your arm (axilla)
• Have had previous hormone therapy or chemotherapy for your breast cancer
• Have had any other cancer in the past, apart from basal cell skin cancer or carcinoma in situ of the cervix
• Are pregnant

Trial design

This is a randomised trial. You will be put into one of the two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will be told which group you are in before you have your sentinel node biopsy.

Everyone taking part will have a sentinel node biopsy. If the sentinel node does not contain cancer cells then you won’t need any more treatment to your lymph nodes. If you have cancer cells in your sentinel lymph node you will have been randomised to 1 of 2 treatment groups.

If you are in group1, you will have an operation to remove all the lymph glands from under your arm (axillary clearance). You will come back to hospital to have this operation at a later date. If you need to have chemotherapy as part of your breast cancer treatment, you will have this after the operation to remove your lymph nodes.

If you are in group 2, you will have radiotherapy to the armpit to kill off the remaining cancer cells. You will have radiotherapy 5 days a week for 5 weeks. If you need to have chemotherapy as part of your breast cancer treatment, you will have the radiotherapy after you have finished your chemotherapy.

Everyone taking part will fill in a questionnaire before the sentinel node biopsy. If, after your sentinel node biopsy, you need to have treatment to your lymph nodes, you will fill in this questionnaire again 1, 2, 3 and 5 years after treatment. The questionnaire will ask you how you are feeling and what side effects you are having. It is called a quality of life questionnaire.

Hospital visits

You will go to the hospital to have some tests before you take part in the trial. These include

• Physical examination
• Mammogram of both breasts

You may also have an ultrasound of your breasts and the lymph nodes under your arm.

After the treatment, everyone taking part will see the trial doctors at least once a year for 5 years. You may see the doctors more often than this, depending on the usual practice at your hospital. You will have a physical examination and a mammogram at each visit. If you had treatment to your lymph nodes, the doctors will check how well you can move your arm after 1, 3 and 5 years.

Side effects

The radioactive injection used for sentinel node biopsy, contains a very small amount of radioactivity. There are no known risks from having this injection, although some patients have had an allergic reaction to the blue dye.

A sentinel lymph node biopsy has possible side effects. These are

• Infection
• A collection of fluid around the biopsy site, called a seroma

If you have surgery to remove more lymph nodes, the possible side effects are

• Infection
• Pain
• A restriction of arm movement
• A collection of fluid around the operation site (a seroma)
• Swelling of the arm (lymphoedema)

If you have radiotherapy to treat your lymph nodes, the possible side effects are

• Redness and soreness of the skin
• Tiredness
• Swelling of the arm (lymphoedema)