Background and Study Aim:

Each year in the UK, about 15,000 women undergo mastectomy and lymph node surgery. One in three have breast reconstruction, while others opt for implants or no reconstruction. Many patients also need radiotherapy, which can cause:

  • Delays to treatment if complications arise after reconstruction
  • Damage to reconstructions, leading to firmness, shrinkage, unevenness, and discomfort

Because of this, many hospitals avoid immediate reconstruction if radiotherapy is required, leaving women to wait months, with two-thirds never receiving reconstruction at all.

Research shows that giving radiotherapy before mastectomy and reconstruction is safe, equally effective for cancer control, and may preserve reconstruction quality. This approach could improve satisfaction with appearance and comfort, reduce treatment delays, and support faster recovery. Ultimately, better reconstruction outcomes can enhance body image, confidence, and overall wellbeing.

We are conducting a large study with 450 patients across 26 NHS hospitals to confirm these early findings. We will compare radiotherapy before mastectomy and reconstruction to radiotherapy after mastectomy and reconstruction.

Who can participate?

Patients aged over 18 years old who will require treatment for breast cancer which will involve mastectomy with breast reconstruction and radiotherapy

What does the study involve?

Women will be randomly allocated to one of two groups. One group will receive radiotherapy to the breast before mastectomy and reconstruction and the other will receive radiotherapy after mastectomy and reconstruction (standard of care). All women will receive the same number of hospital visits and assessments.

    • Baseline Visit - You will be asked to complete 2 questionnaires relating to quality of life.

We will also require medical photographs ahead of your surgery. The photographs will be anonymous and will not contain your face.

    • Radiotherapy visits - If you are allocated to have radiotherapy first, it will take place 2-6 weeks before your breast surgery. If you have having chemotherapy as the first treatment, the radiotherapy will happen 3-6 weeks after completion of chemotherapy.

If you are allocated to the receive radiotherapy after surgery, it is given when you are medically fit following your operation, usually around 6-8 weeks after.

In both groups, the radiation dose will be the same. At the end of treatment, we will record any side effects from treatment

  • Mastectomy - Your mastectomy and reconstruction will be performed in the same way regardless of which group you are in and will be discussed and planned with you ahead of time.
  • Follow Up Visits - You will receive follow up visits with your team several times after your surgery, at around 2 weeks, at 3, 6 and 9 months and at 1 and 2 years. At these visits we will monitor for outcomes such as wound healing, status of reconstruction and success in long-term cancer control.

You will be asked to complete quality-of-life questionnaires at each visit.

We will ask for your feedback on how you feel about your breast reconstruction through questionnaires at 3 months, 1 year and 2 years after surgery to find out which group is more satisfied with their breasts and quality of life. We will also collect more photos at year 1 and 2 to record the cosmetic outcome.

What are the possible benefits and advantages of taking part?

There are no additional treatment benefits.

Regardless of which group you are in you will receive radiation therapy and mastectomy with an immediate breast reconstruction using your own body tissues.

There may be some benefits to preoperative radiation, but at this stage, these are unproven, and this is the reason we are conducting this study.

Taking part in the study will benefit other patients with a similar condition in the future, particularly regarding breast-related quality of life and accelerating the time between diagnosis and completion of local therapy to the breast.

Preoperative radiation therapy is currently not standard of care, and so the only way to receive this therapy is being a participant in this research study and being randomly assigned to the preoperative radiotherapy group.

What are the possible disadvantages and risks of taking part?

You may experience some side effects from the radiotherapy, but we do not expect these to differ from if you were not taking part in the study

    • Challenges in deciding whether radiotherapy is needed before surgery

 Doctors may need to decide whether to treat just the breast or also nearby lymph nodes

Treating certain lymph nodes is tricky because they’re close to the heart and lungs

If you have radiotherapy before surgery, and cancer is later found in these lymph nodes, it can be harder to treat that area again with radiation, but most patients will go on and receive other drug treatments as part of standard management that we know can eliminate any residual cancer cells.

    • Additional radiological biopsies, radiation from surgical procedure(s) and/or additional scans

If you’ve had chemotherapy before radiotherapy, doctors may need to do another biopsy to check if any cancer remains.

You might also have extra scans (PET/CT) and a small operation to check lymph nodes. These involve small amounts of radiation, which carries a very low long-term risk.

Technical challenges during microsurgical anastomosis.

If your breast reconstruction uses your own tissue, surgeons must connect tiny blood vessels.  Radiation before surgery can make these vessels more fragile, and sometimes they need to be reconnected during the operation. Despite this, previous patients still had 100% successful reconstructions.

  • Anxiety in answering sensitive questions in surveys or interviews
  • Pregnancy Radiotherapy can harm an unborn baby, so pregnant women or those planning pregnancy during the study cannot take part.

Where is the study Run from?

天美传媒 (UK) in collaboration with Royal Marsden NHS Foundation Trust

When is the study starting and how long is it expected to run for?

Estimated recruitment between March 2026 – Feb 2029

Who is funding the study?

National Institute for Health Research

Who is the main contact?

1. Dr Daniel Leff, d.leff@imperial.ac.uk 

2. Ms Puja Jadav (public contact), prada2@imperial.ac.uk