Not yet recruitingInterventional

Evaluating the impact of pre-operative versus post-operative radiotherapy in patients undergoing mastectomy with autologous breast reconstruction

This study looks at the best time to give radiotherapy to women having a mastectomy and breast reconstruction using their own body tissue. Currently, radiotherapy often happens after surgery, which can lead to delays and problems with the reconstructed breast. Some early research suggests that having radiotherapy before surgery might be just as good for cancer control and could help the reconstructed breast look and feel better. This large study, involving 450 patients across 26 NHS hospitals, wants to find out if giving radiotherapy first can improve breast appearance, make recovery quicker, and boost women's confidence and overall well-being. Participants will be split into two groups to compare these timings.

At a glance

Status

Not yet recruiting

Sponsor

Imperial College London

Enrolment target

450

Start

15 Jun 2026

Estimated completion

28 Feb 2029

Breast cancers requiring mastectomy and radiotherapy, and suitable for immediate autologous microvascular breast reconstruction.

What is this study about?

When women have breast cancer treatment, especially a mastectomy (removing the breast), many also need radiotherapy to help prevent the cancer from coming back. For some, rebuilding the breast right away using their own body tissue (called autologous reconstruction) is an option. However, radiotherapy can sometimes cause issues with the new breast, like making it feel firm, shrink, or look uneven. Because of this, hospitals often delay immediate reconstruction if radiotherapy is needed, which means some women never get the reconstruction they hoped for. This can be really upsetting and affect how they feel about their body.

Researchers are now exploring a different approach: giving radiotherapy before the mastectomy and reconstruction. Early findings suggest this might be safe and equally good at controlling the cancer, while also improving the quality and appearance of the reconstructed breast. If this proves true, it could mean women face fewer delays in their treatment, recover faster, and are happier with their new breast. Feeling good about their body image can make a big difference to a woman's confidence and overall well-being after cancer.

This study, called the Pre-operatIve Radiotherapy And DIEP flAP ReconStruction Trial-II, is a large and important research project involving 450 patients across 26 NHS hospitals in the UK. Its main goal is to compare these two timings for radiotherapy – before surgery versus after surgery – to definitively see which method leads to better outcomes, especially for the look and feel of the reconstructed breast, and for the patient's satisfaction and quality of life.

Key takeaways

This study compares radiotherapy before vs. after breast cancer mastectomy and reconstruction.
It aims to improve breast reconstruction appearance, satisfaction, and recovery time.
Participation involves random assignment to one of two radiotherapy timings.
You'll have regular follow-up visits and complete questionnaires for two years.
The study focuses on breast reconstruction using your own body tissue.
Your contribution will help future breast cancer patients benefit from better treatment plans.

Who may be eligible?

This study is for women aged 18 or over who have been diagnosed with breast cancer that needs specific treatments. You must be having a mastectomy (breast removal) and also require radiotherapy. Crucially, you should also be planning to have your breast rebuilt using your own body tissue, rather than an implant.

Your medical team must agree that you need both a mastectomy and radiotherapy. They also need to confirm that rebuilding your breast with your own tissue is a suitable option for you. If you are pregnant or breastfeeding, or if your cancer has spread to other parts of your body, unfortunately, you won't be able to join this study.

The main idea is to see if giving radiotherapy before your mastectomy and reconstruction helps you recover better and makes your reconstructed breast look and feel more natural compared to having radiotherapy afterwards. You can only get radiotherapy before surgery as part of this study.

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.

Are you 18 years old or older?
Do you need treatment for breast cancer that involves a mastectomy?
Do you also need radiotherapy as part of your breast cancer treatment?
Are you suitable for breast reconstruction using your own body tissue (not an implant)?
Are you currently not pregnant or breastfeeding?
Has your cancer not spread to other parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be split randomly into one of two groups, like flipping a coin. One group will receive radiotherapy before their mastectomy and breast reconstruction, and the other group will have radiotherapy after these operations. Everyone in the study will have the same number of hospital visits and assessments.

At the very beginning, you'll have a first visit where you'll complete two questionnaires about your quality of life. Anonymous medical photographs (without your face) will also be taken before your surgery. If you're in the group having radiotherapy first, it will usually be given 2 to 6 weeks before your breast surgery. If you've had chemotherapy, the radiotherapy will happen 3 to 6 weeks after that. If you're in the group having radiotherapy after surgery, it will typically be around 6 to 8 weeks after your operation, once you've recovered well. The amount of radiotherapy everyone receives will be the same.

The mastectomy and breast reconstruction surgery will be planned and carried out in the same way for everyone, regardless of which group they are in. After your surgery, you'll have follow-up appointments with your medical team. These visits will be at about 2 weeks, 3, 6, and 9 months, and then at 1 and 2 years. At these appointments, your healing, the success of your reconstruction, and long-term cancer control will be checked. You'll also be asked to fill out quality-of-life questionnaires at each visit. Additionally, you'll give feedback on your breast reconstruction through questionnaires at 3 months, 1 year, and 2 years after surgery, and more photos will be taken at 1 and 2 years to see how the reconstruction looks.

Potential risks and benefits

There are no guaranteed personal benefits from taking part in this study, as you will receive the same care (radiotherapy, mastectomy, and reconstruction) regardless of which group you are in. However, the information gathered will be very valuable for improving the treatment of other breast cancer patients in the future, particularly regarding their quality of life and the speed of their overall treatment. The main potential disadvantage is that you might experience side effects from the radiotherapy, although these are not expected to be different from what you would experience if you weren't in the study. There's a small chance that if you have radiotherapy before surgery, and cancer is later found in certain lymph nodes, treating that area again with radiation could be harder. You might also need a few extra procedures like biopsies or scans involving small amounts of radiation, which carry a very low long-term risk. For women having reconstruction with their own tissue, there's a small technical challenge as radiotherapy can make blood vessels more fragile, but past studies have shown these reconstructions are still 100% successful. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

St Marys Hospital
City only
London, England
The Royal Marsden Hospital
Approximate
London, England

Common questions

What is the main goal of this study?

The main goal is to find out if giving radiotherapy before breast cancer surgery and reconstruction leads to better results for the reconstructed breast and faster recovery compared to giving it afterwards.

How will I know if I'm in the group that gets radiotherapy before or after surgery?

You'll be randomly assigned to one of the two groups, like flipping a coin, so it's not a choice you make. This helps make the study fair.

Will my doctors treat me differently if I join the study?

No, you will receive the same high standard of care for your breast cancer. The study is about the timing of radiotherapy, not about changing the quality of your overall treatment.

What kind of reconstruction is used in this study?

This study focuses on breast reconstruction using your own body tissue, specifically with techniques like DIEP flaps, where tissue is taken from another part of your body to create a new breast.

How long will I be involved in the study?

You will be followed up for a total of two years after your surgery, with several visits during that time to check on your progress and gather feedback.

How to find out more

Puja Jadav

prada2@imperial.ac.uk +44 (0)20 7594 6017 Official trial record

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