RecruitingNAINTERVENTIONAL

Partial Breast Re-irradiation for Breast Cancer

This study is testing a new, gentler type of radiation therapy, called proton therapy, for women whose breast cancer has returned in the same breast. Often, if breast cancer comes back after initial treatment with surgery and radiation, a full mastectomy is recommended. This trial explores whether carefully targeted proton therapy can treat the new cancer after a second breast-sparing surgery. Researchers want to see if this new approach causes fewer severe skin side effects compared to older methods. It aims to find a way to treat recurrent breast cancer while keeping the breast and potentially reducing treatment-related discomfort for patients who have already had radiation.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

Start

28 Aug 2025

Estimated completion

01 Oct 2029

Breast Cancers

What is this study about?

Breast cancer is very common, and after surgery, radiation therapy is often used to help stop it from coming back in the same breast. Usually, this means treating the whole breast. While this works well for many, sometimes the cancer can still return years later in the treated breast. If this happens, removing the breast (mastectomy) is often the standard advice, especially if you've already had radiation.

This new study is looking at a different way to treat these cancers that come back. It's for women who have had a second surgery to remove the new cancer in the same breast and now need more radiation. Instead of a mastectomy, or another round of traditional radiation that might be harsh on the skin, this study uses a special type of radiation called proton therapy. Proton therapy is very precise and aims to target only the cancer area, hopefully reducing damage to nearby healthy tissue.

The main goal of this study is to see how safe this new proton therapy is. Specifically, it wants to find out if it causes fewer severe skin reactions within the first six months after treatment. By being more precise, doctors hope to control the cancer that has returned while making the treatment much easier on the patient's body, especially their skin, which has already received radiation before.

Key takeaways

This study tests a new form of radiation (proton therapy) for breast cancer that has come back.
It's for women who've had a second surgery for their recurrent breast cancer.
The main goal is to see if this new treatment causes fewer severe skin problems.
It could offer an alternative to a mastectomy for some women.
Treatment involves 15 daily proton therapy sessions over about three weeks.

Who may be eligible?

This study is for women aged 18 or over who have had breast cancer return in the same breast. You would have already had radiation therapy to that breast in the past, and at least a year must have passed since your last radiation treatment. You must have had a second surgery to remove this new cancer, and the surgeon must have been able to remove all of it with clear edges, meaning no cancer cells were left behind at the edges of the removed tissue.

The new cancer should be small, less than 3cm, and your lymph nodes should not show signs of cancer spreading. You also need to be well enough to take part and understand what the study involves, and you shouldn't have cancer elsewhere in your body. If you are pregnant or breastfeeding, or currently having chemotherapy, you cannot join. Having some other specific serious health conditions or participating in certain other trials would also mean you can't join this one.

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.

Is your breast cancer a recurrence in the same breast you've had treated before?
Have you already had surgery to remove this new breast cancer?
Has it been at least a year since your last breast radiation treatment?
Do you feel generally well and have no cancer spread to other parts of your body?
Are you 18 or older and not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a special type of radiation therapy called proton beam therapy to a small part of your breast. This will involve 15 daily radiation sessions, usually Monday to Friday, over about three weeks. Before starting, you will have planning scans to make sure the radiation is aimed precisely at the right area.

After your treatment finishes, doctors will check your skin closely to see how it's reacting to the radiation. The main thing they will look for is any severe skin redness, soreness, or blistering within the first six months after your treatment starts. You will have regular follow-up appointments with the study team to monitor your progress and check for any side effects. The total duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

The potential benefit of taking part in this study is receiving a new, highly targeted radiation treatment that might offer effective control of your recurrent breast cancer with potentially fewer side effects, especially to your skin, compared to traditional methods or the alternative of a mastectomy. However, as with all treatments, there are potential risks, including side effects from the radiation, even with this advanced technique. These could include skin reactions, fatigue, or other issues, although the study aims to minimise severe skin problems. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital Heidelberg, Department Radiation Oncology
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What is 'proton therapy'?

Proton therapy is a very precise type of radiation that uses tiny particles called protons to target cancer cells, aiming to cause less damage to healthy tissue nearby.

Why is this study important for women with recurrent breast cancer?

It's important because it explores a new way to treat breast cancer that has returned in the same breast, potentially offering an alternative to mastectomy and reducing side effects from previous treatments.

Will I have to have an operation if I join this study?

Yes, this study is for women who have already had a second surgery to remove the new cancer in their breast before starting the special radiation therapy.

What kind of side effects are they looking for?

The main thing they're looking for is any severe skin reactions, like bad redness, swelling, or blistering, within six months of starting the proton therapy.

Can I still take hormonal therapy for my breast cancer?

Yes, taking hormonal therapy (like tamoxifen or an aromatase inhibitor) for your breast cancer is allowed while you are in this study.

How to find out more

Eva Meixner, MD

eva.meixner@med.uni-heidelberg.de 0049 6221 56 8201 Official trial record

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