Active not recruitingNAINTERVENTIONAL

Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast

This study explores whether some women with a very early type of breast cancer, known as ductal carcinoma in situ (DCIS), can safely skip radiotherapy after having surgery to remove the lump. Typically, radiotherapy is given to reduce the chance of the cancer coming back. However, doctors are realising that some women are at such a low risk of recurrence that they might not need this extra treatment, which can have side effects. The study aims to use new biological tests, alongside standard checks like tumour size and grade, to identify these specific women. The goal is to avoid 'over-treating' patients who don't need it, improving their quality of life and potentially reducing healthcare costs, while still ensuring their cancer is well-managed.

At a glance

Status

Active not recruiting

Phase

Sponsor

UNICANCER

Enrolment target

295

Start

10 May 2019

Estimated completion

14 Nov 2034

DCIS Breast Cancer Low Risk DCIS Breast Conserving Surgery Radiotherapy Omission

What is this study about?

When someone has been diagnosed with a very early form of breast cancer called ductal carcinoma in situ, or DCIS, it means abnormal cells are found within the milk ducts of the breast but haven't spread outside. After surgery to remove these cells, radiotherapy is usually given to help stop the DCIS from coming back. This is because, historically, studies have shown that radiotherapy significantly lowers the chance of the DCIS returning in the breast.

However, doctors are now understanding that not all DCIS is the same. Some forms are very low-risk, meaning the chance of them coming back is already very small. For these women, having radiotherapy might be an unnecessary treatment that could cause side effects without a significant extra benefit. Researchers have been trying to find reliable ways to identify these low-risk cases, but it's been difficult to pinpoint exactly who can safely miss out on radiotherapy.

This study is important because it's looking into combining traditional ways of assessing risk (like how old you are, the size of the DCIS, and how the cells look under a microscope) with newer biological tests. These biological tests look at specific characteristics of the DCIS cells themselves, which can give doctors a better idea of how aggressive the DCIS might be. By doing this, the hope is to create a clearer picture of who truly has 'very low-risk' DCIS. This could help doctors recommend avoiding radiotherapy for these women, meaning fewer side effects and potentially a better quality of life, without increasing their risk of recurrence.

Key takeaways

This study evaluates if radiotherapy can be safely skipped for certain low-risk DCIS patients.
It aims to identify very low-risk women using advanced biological tests alongside standard checks.
Avoiding radiotherapy could mean fewer side effects and better quality of life for suitable patients.
Participants will have regular follow-up to monitor their health.
The goal is to prevent 'over-treatment' for low-risk early breast cancer.

Who may be eligible?

This study is looking for women aged 50 or older who have been diagnosed with a specific type of early breast cancer called DCIS. You will need to have had breast-conserving surgery, which means the lump was removed but not the whole breast. Importantly, the DCIS must not have spread, and there should be clear margins after surgery, meaning no cancer cells were left behind at the edges.

Your DCIS cells will also need to have certain characteristics when tested in the lab. For example, they should show specific markers that suggest it's a lower-risk type. You also need to be generally well and able to attend all study appointments.

There are also some reasons why you couldn't join. For instance, if you've already had hormone treatment for breast cancer, or if you've had invasive breast cancer before (this is different to DCIS). Your medical team will carefully check all these details to see if you might be a good fit for the 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 50 or over?
Have you been diagnosed with DCIS that has not spread?
Have you had surgery to remove the DCIS, keeping your breast?
Were the edges of the removed DCIS clear of cancer cells?
Are your DCIS cells of a 'low or intermediate' grade?
Are you generally well and able to attend appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference from standard care is that you would not receive radiotherapy after your breast-conserving surgery for DCIS. You would have regular check-ups and follow-up appointments with your medical team, similar to women who do have radiotherapy, to monitor your health and ensure the DCIS does not return. These appointments would involve physical examinations and possibly mammograms or other scans as needed, spread out over several years. The study team will explain the exact schedule of visits and tests during your consented participation.

Potential risks and benefits

A potential benefit of joining this study is avoiding radiotherapy, which can have side effects like skin irritation, fatigue, or breast pain. For women with very low-risk DCIS, avoiding radiotherapy could mean fewer treatments without increasing the chance of the DCIS coming back. However, a potential risk is that by not having radiotherapy, there might be a slightly higher chance of the DCIS recurring in the breast compared to if you had received radiotherapy. The researchers are trying to identify a group where this risk is very low. You are free to withdraw from the study at any time without affecting your medical care.

Locations (37)

Institut de Cancérologie de l'Ouest -Site Paul Papin
Verified postcode
Angers, France
Institut Sainte Catherine
Verified postcode
Avignon, France
Centre d'Oncologie et de Radiothérapie du Pays Basque
Verified postcode
Bayonne, France
Clinique Belharra
Verified postcode
Bayonne, France
Institut Bergonie
Verified postcode
Bordeaux, France
Centre Francois Baclesse
Verified postcode
Caen, France
Centre Hospitalier du Cotentin
Verified postcode
Cherbourg, France
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France
CHIC Créteil
Verified postcode
Créteil, France
Hôpital Henri Mondor
Verified postcode
Créteil, France
Centre Georges Francois Leclerc
Verified postcode
Dijon, France
Centre Hospitalier De Lagny Sur Marne
Verified postcode
Jossigny, France

Common questions

What is DCIS?

DCIS stands for Ductal Carcinoma In Situ. It's a very early, non-invasive form of breast cancer where abnormal cells are found only inside the milk ducts and haven't spread.

What is radiotherapy?

Radiotherapy uses high-energy rays to kill cancer cells, usually given after surgery to reduce the chance of cancer coming back in the treated area.

Why might I not need radiotherapy?

For some women with very low-risk DCIS, the chance of the cancer returning is so small that the benefits of radiotherapy might not outweigh its potential side effects.

What are 'biological markers'?

These are special tests on your DCIS cells that help us understand how active or aggressive the cells are, giving a more detailed picture than just looking under a microscope.

Can I still get standard treatment if I join?

This study is looking at not having radiotherapy. If you decide to join, you would not receive it initially. However, you can withdraw from the study at any time and discuss all treatment options with your doctor.