Active not recruitingNAINTERVENTIONAL

Breast-Conserving Surgery and Whole-Breast Radiation Therapy With or Without Additional Radiation Therapy to the Tumor in Treating Women With Ductal Carcinoma in Situ (BONBIS)

This study is for women with a very early type of breast cancer called ductal carcinoma in situ (DCIS). This type of cancer is contained in the milk ducts and hasn't spread. After having surgery to remove the cancerous cells, all women in the study will receive a standard type of radiation therapy to the whole breast. Half of these women will also receive a small, extra dose of radiation directly to the area where the tumour was. The main goal is to compare these two radiation approaches to understand which one is better at preventing the cancer from coming back in the same breast. Researchers will also look at side effects, how the breast looks after treatment, and overall quality of life.

At a glance

Status

Active not recruiting

Phase

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

2,004

Start

01 Nov 2008

Estimated completion

01 Oct 2029

Breast Cancer

What is this study about?

This study is all about helping women who have a very early form of breast cancer called ductal carcinoma in situ, or DCIS. Think of DCIS as abnormal cells that are completely contained within the milk ducts of the breast and haven't spread to other areas. Many women will have surgery to remove these cells. After surgery, radiation therapy is often used to get rid of any remaining tiny cancer cells that might be left behind, helping to reduce the chance of the cancer coming back.

The main question this study wants to answer is whether, after surgery and standard whole-breast radiation therapy, adding a little extra radiation directly to the spot where the tumour was makes a difference. Some doctors believe this extra boost of radiation might be more effective, while others aren't so sure. This study aims to compare these two options carefully. By doing this, we hope to find the best way to treat DCIS, giving women the best chance of staying cancer-free and maintaining a good quality of life.

Researchers will be looking at several things. The most important is how well the treatments stop the cancer from returning in the same breast. They will also keep a close eye on any side effects patients might experience, how the treated breast looks, and generally how well women feel during and after treatment. This will help doctors understand which treatment plan offers the best balance of effectiveness and comfort.

Key takeaways

This study evaluates different radiation approaches for very early breast cancer (DCIS).
All participants will have breast-conserving surgery and standard whole-breast radiation.
Half will also receive a small, extra dose of radiation to the tumour area.
The main aim is to see which approach is better at preventing the cancer from returning.
Side effects, breast appearance, and quality of life will also be carefully monitored.
Participation involves commitments for treatment, follow-up, and regular check-ups for 15 years.

Who may be eligible?

To join this study, you must be a woman aged 18 or older with a specific type of very early breast cancer called ductal carcinoma in situ (DCIS). This means the cancer cells are only in the milk ducts and haven't spread. You must have had surgery to remove the DCIS, and the doctors must be confident that all the visible cancer was removed.

There are also some general health requirements. You should be in reasonably good health, able to carry out most daily activities, and not have any serious, uncontrolled medical conditions like heart, kidney, or lung problems. You also shouldn't be pregnant. It's important that you're able to commit to the long-term follow-up appointments.

Some conditions would prevent you from joining. For example, if you have other types of cancer (except for certain skin cancers or cervical cancer treated early), or if the DCIS was found in more than one area of the breast in a way that couldn't be fully removed with breast-conserving surgery, you might not be eligible. Also, if you've had breast cancer in both breasts, or there are psychological or social reasons that might make it hard for you to stick to the study's plan, you wouldn't be able to take part.

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 18 or older?
Do you have a diagnosis of Ductal Carcinoma in Situ (DCIS) that hasn't spread?
Have you had breast-conserving surgery for your DCIS?
Are you generally well and able to manage most daily activities?
Are you able to attend appointments for many years for follow-up?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have surgery to remove the DCIS. About 12 weeks after your surgery, you will be randomly assigned to one of two groups. This means a computer will decide which treatment plan you receive, just like flipping a coin, to make sure the study is fair.

One group will receive standard whole-breast radiation therapy, which involves daily treatments five days a week for five weeks. The other group will receive the same standard whole-breast radiation, but also an additional small dose of radiation directly to the area where your tumour was. This extra dose will be given daily for about two weeks, only on weekdays.

Throughout the study, you'll be asked questions about your quality of life to understand how you are feeling. After all your treatments are finished, you'll have check-ups every six months for five years. After that, you'll have annual check-ups for another ten years. This long follow-up helps doctors see the long-term effects of the treatments.

Potential risks and benefits

Participating in a clinical study means you might receive a treatment that could be more effective than standard care, or help us learn important information for future patients. However, there's also a chance the new approach might not be better, or could have different side effects. All treatments carry some risks, and radiation therapy can cause side effects like skin irritation, tiredness, or swelling. The study doctors and nurses will explain all potential risks and benefits in detail. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Verified postcode
Montpellier, France

Common questions

What is DCIS?

DCIS stands for Ductal Carcinoma in Situ. It's a very early form of breast cancer where abnormal cells are found only inside the milk ducts and haven't spread to other parts of the breast.

What is 'breast-conserving surgery'?

This is surgery to remove only the part of the breast where the cancer is, rather than the whole breast. It's sometimes called a lumpectomy.

What is radiation therapy?

Radiation therapy uses high-energy X-rays to kill cancer cells or stop them from growing. It's given from a machine outside the body.

Why might I get 'additional radiation'?

The study wants to find out if giving a little extra radiation directly to the spot where the tumour was—after standard radiation—can better prevent the cancer from coming back.

How long will I be followed up after treatment?

You will have regular check-ups for five years, and then yearly check-ups for an additional ten years, so a total of 15 years to monitor your health and treatment effects.