CompletedInterventional

SUPREMO, an MRC Phase III randomised trial to assess the role of adjuvant chest wall irradiation in 'intermediate risk' operable breast cancer following mastectomy

After surgery to remove a breast (a mastectomy), some women have what doctors call 'intermediate risk' breast cancer. This means the cancer is not very small, but it has not spread widely either—it may have reached between one and three lymph nodes under the arm. Currently, doctors across the UK are unsure whether radiotherapy to the chest wall is always needed for this group. Radiotherapy helps kill leftover cancer cells, but it also causes side effects like skin irritation and fatigue. In the SUPREMO trial, women are randomly placed into one of two groups. One group has radiotherapy to the chest wall, while the other group does not. Both groups receive all other recommended treatments, such as chemotherapy or hormone therapy. The aim is to find out which approach offers the best long-term health and quality of life.

At a glance

Status

Completed

Sponsor

University of Edinburgh, Lothian Health Board and the Common Services Agency (UK)

Enrolment target

1,600

Start

01 Oct 2005

Estimated completion

28 Nov 2014

Breast cancer

What is this study about?

When treating breast cancer, surgery is often the first major step. If you have had a mastectomy, your entire breast has been removed. For women with very high-risk cancer, radiotherapy to the chest area is usually given to lower the chance of the cancer coming back. For women with very low-risk cancer, it is usually not needed. However, for women in the middle—known as 'intermediate risk'—specialists do not yet have clear evidence about whether radiotherapy does more good than harm.

The SUPREMO trial was set up to answer this important question. It compares two standard approaches: having chest wall radiotherapy after surgery, versus having regular monitoring without chest wall radiotherapy. By comparing large numbers of women, researchers hope to see if radiotherapy truly lowers the chance of cancer returning and helps women live longer, or if skipping it is just as safe.

Taking part helps doctors understand how to tailor breast cancer care more accurately in the future. If the trial shows that radiotherapy is not needed for everyone, thousands of women could be spared the daily hospital visits and side effects of treatment. On the other hand, if it clearly helps, doctors will know to recommend it with confidence.

Key takeaways

SUPREMO is testing whether radiotherapy to the chest wall is needed after a mastectomy for intermediate-risk breast cancer.
Participants are randomly chosen to either receive chest wall radiotherapy or have careful follow-up without it.
All participants receive their other planned treatments, such as hormone therapy or chemotherapy.
The goal is to find out if skipping radiotherapy is safe and helps patients avoid unnecessary side effects.
Taking part is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is for women who have had a total mastectomy to treat invasive breast cancer in one breast. The surgical team must have removed the tumour with a clear border (or 'margin') of healthy tissue around it. In addition, the lymph nodes under the arm must have been checked or cleared.

To be considered 'intermediate risk', your cancer will usually have specific features. For example, the tumour may have been between 2 and 5 centimetres wide, or it may have spread to between one and three lymph nodes under your arm. Women who had chemotherapy before their mastectomy to shrink the tumour can also join, provided their cancer met similar intermediate-risk criteria.

This trial is not suitable for women whose cancer has spread to other distant parts of the body (secondary or metastatic breast cancer), or for those who had a lumpectomy (breast-conserving surgery) rather than a full mastectomy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am female and have been diagnosed with breast cancer in one breast.
I have had a complete mastectomy with clear margins.
My cancer is considered intermediate risk (for example, 1 to 3 affected lymph nodes or specific tumour sizes).
My cancer has not spread to distant parts of my body.
I have had my underarm lymph nodes checked or cleared by surgery.

Answer every question to see your result.

What does participation involve?

If you take part, a computer will randomly place you into one of two groups. Neither you nor your doctor can choose which group you join. One group receives chest wall radiotherapy, while the other group does not. Radiotherapy is given as daily outpatient hospital visits, Monday to Friday, usually for about three to five weeks. Both groups will continue to receive any other treatments advised by their cancer team, such as hormone tablets, targeted therapies, or chemotherapy. You will attend regular clinic visits over several years so your care team can monitor your health, check for any signs of the cancer returning, and record how you are feeling.

Potential risks and benefits

If you receive radiotherapy, it may reduce the risk of cancer coming back in the chest wall, but it can cause side effects like red or sore skin, tiredness, and rare long-term effects on the heart or lungs. If you do not have radiotherapy, you avoid these side effects, but doctors are studying whether this slightly changes the risk of the cancer returning. Whichever group you are in, your health will be watched very closely. Taking part is completely your choice, and you can change your mind and leave the study at any time without your NHS care being affected.

Locations (1)

Western General Hospital
Approximate
Edinburgh, Scotland

Common questions

Why can't I choose whether to have radiotherapy?

To make the study fair and scientifically reliable, a computer randomly assigns participants to each group. This ensures both groups are as similar as possible so the results are accurate.

Will I still receive my other breast cancer treatments?

Yes. Taking part does not stop you from receiving other standard treatments your team recommends, such as chemotherapy, hormone therapy, or targeted drugs.

What does chest wall radiotherapy feel like?

The treatment itself is painless and only takes a few minutes each day, similar to having an X-ray. However, over time, the skin in the treated area can become red, dry, or tender.

How long will I be followed up in the study?

Researchers track participants' health for up to 10 years to understand the long-term impact on cancer recurrence and overall wellbeing.

What happens if I decide to stop taking part?

You are free to leave the trial at any point. Your doctors will continue to give you the standard NHS care best suited to your needs.

How to find out more

Ian Kunkler

i.kunkler@ed.ac.uk +44 (0)131 537 2214 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.