RecruitingOBSERVATIONAL

Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity

This study aims to make radiotherapy for breast cancer more personal. Sometimes, radiotherapy can cause side effects like skin changes that affect how a person feels. Currently, everyone often gets a standard dose of radiotherapy, but this study uses a new test called NovaGray Breast®. This test helps doctors predict who might be more likely to get side effects from radiotherapy. By knowing this, doctors can adjust the treatment, perhaps by reducing the amount of breast tissue treated, giving slightly fewer but stronger doses (called hypofractionation), or in some cases, even suggesting that radiotherapy might not be necessary. The goal is to reduce unwanted side effects while still effectively treating the cancer, especially for women aged 65 and over with a specific type of early breast cancer.

At a glance

Status

Recruiting

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

500

Start

23 May 2019

Estimated completion

01 Jun 2026

Breast Cancer

What is this study about?

When people have breast cancer, radiotherapy is often a very important part of their treatment to help stop the cancer from coming back. However, like any treatment, radiotherapy can sometimes cause side effects, such as changes to the skin or the way the breast looks. These side effects, even if they're not severe, can sometimes affect a person's quality of life and how they feel about themselves.

At the moment, radiotherapy is usually given in a fairly standard way to most people. But we know that everyone's body is different, and some people might react more strongly to treatment than others. This study is exploring a new approach that uses a special test, called NovaGray Breast®, which helps predict how likely an individual is to experience these side effects. This test looks at certain cells in your blood and combines it with other important information about your health and cancer type.

Using the information from this test, along with other details about your specific breast cancer, doctors hope to tailor radiotherapy treatment more precisely. This could mean adjusting the amount of breast tissue treated, or using a slightly different schedule for the radiation. In some cases, for very specific types of early breast cancer with a low risk of coming back, it might even mean that radiotherapy could potentially be avoided altogether. The main goal is to find the best way to treat the cancer while significantly reducing the chance of unwanted side effects, making the treatment kinder and more effective for each individual.

Key takeaways

This study aims to make breast cancer radiotherapy more personal.
It uses a new test (NovaGray Breast®) to predict who might get more side effects.
The goal is to reduce side effects like skin changes while effectively treating cancer.
Treatment might be adjusted by changing the dose, area, or even avoiding radiotherapy in specific low-risk cases.
It's primarily for women aged 65+ with certain types of early breast cancer.
The study seeks to improve quality of life after breast cancer treatment.

Who may be eligible?

This study is looking for women aged 65 or older who have had surgery to remove breast cancer but still have their breast (known as conservative breast cancer surgery). They should have early-stage breast cancer, meaning the tumour is not too large and hasn't spread to the nearby lymph nodes, and it must be a specific type of cancer called "Luminal A". It's also important that the cancer has been completely removed with clear borders in the surgery.

To be considered, you should only need radiotherapy to the whole breast, not to the lymph nodes or other areas. You should also be within easy travel distance for follow-up appointments and be able to provide written permission to take part.

However, some people won't be able to join. This includes if your cancer has spread to other parts of your body, or if you've already had a full mastectomy (removal of the whole breast). If you've had certain other cancers recently, received chemotherapy before your surgery, or have other serious health problems that might make long-term follow-up difficult, you might also not be suitable for 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 a woman aged 65 or older?
Did you have surgery for breast cancer where your breast was kept (not a full mastectomy)?
Is your breast cancer an early stage and of the 'Luminal A' type?
Has your cancer not spread to distant parts of your body?
Do you only need radiotherapy to the breast itself, not to lymph nodes?
Can you easily travel to appointments for follow-up?
Have you not had chemotherapy before your breast cancer surgery?

Answer every question to see your result.

What does participation involve?

The details of what taking part involves aren't fully described but generally, in a clinical trial like this, you would likely have some initial assessments, including the special NovaGray Breast® test. This test involves a blood sample. You would then undergo radiotherapy tailored to your individual risk of side effects, as determined by the test and your other medical information. You would have regular follow-up appointments, which may involve physical exams and scans, to monitor the effectiveness of the treatment and any side effects. The total duration of follow-up for radiotherapy studies can be several years to see long-term effects, but the frequency of visits usually reduces over time.

Potential risks and benefits

A potential benefit of joining this study is that you might receive a more personalised radiotherapy treatment, which could lead to fewer or less severe side effects, improving your quality of life after breast cancer. However, as with any new approach, there's always a possibility that the new method might not be as effective as standard treatment, or might have unexpected risks. The researchers are carefully studying these new ways of giving radiotherapy. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Institut Régional du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting

Common questions

What is 'radiosensitivity'?

Radiosensitivity means how sensitive your body's healthy cells are to the effects of radiation. Some people's healthy cells are more easily affected than others.

What is the NovaGray Breast® test?

It's a special test that combines a blood test (looking at how certain immune cells react to radiation) with other information about you to help predict your risk of side effects from radiotherapy.

Will this study change my cancer treatment?

Yes, the aim is to personalise your radiotherapy treatment based on the results of the special test, potentially adjusting the dose, area treated, or even suggesting it might not be needed for some very low-risk cases.

What happens if I get side effects?

The study aims to reduce side effects, but if they do occur, your medical team will monitor them closely and manage them as part of your ongoing care.

How long would I be involved in the study?

Radiotherapy studies typically involve follow-up for several years (e.g., 5-10 years) to track long-term effects and the cancer's return, though clinic visits usually become less frequent over time.

How to find out more

Jean-Pierre BLEUSE, MD

drci-icm105@icm.unicancer.fr 0467613102 Official trial record

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