RecruitingPHASE3INTERVENTIONAL

NeoRad Breast Cancer Study

The NeoRad study is a clinical trial focusing on women with high-risk breast cancer who have received chemotherapy before surgery. Doctors often give radiation therapy after surgery, but this study is testing if giving it *before* surgery might be more effective. The main aim is to see if early radiation can help prevent the cancer from coming back (improve disease-free survival) and also lead to fewer long-term side effects from the treatment. This is important because the timing of radiation therapy for these patients hasn't been thoroughly compared in a large study before, and finding a better approach could improve patient outcomes and quality of life.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bielefeld University

Enrolment target

1,826

Start

01 Feb 2024

Estimated completion

31 Mar 2034

Breast Cancer

What is this study about?

The NeoRad Breast Cancer Study is looking into the best time to give radiation therapy to women with certain types of breast cancer. If you have breast cancer that is considered 'high-risk' and you've already had chemotherapy before your surgery, doctors usually recommend radiation therapy afterwards. This is to try and kill any remaining cancer cells and stop the cancer from returning.

However, this study wants to see if doing things a little differently might be better. It's comparing two approaches: giving radiation therapy *before* surgery versus the usual method of giving it *after* surgery. The main goals are to see if giving radiation earlier can help you stay cancer-free for longer and if it leads to fewer long-term side effects caused by the radiation itself. Scientists hope that understanding the best timing for radiation could improve how we treat breast cancer and help patients feel better in the long run.

This is a 'Phase 3' study, which means it's a large study comparing a new approach (radiation before surgery) to the current standard care (radiation after surgery). These kinds of studies are really important for finding better ways to treat diseases and improve patient lives. The study is led by Professor Dr. Christiane Matuschek, with support from Professor Dr. Wilfried Budach and Professor Dr. Tanja Fehm.

Key takeaways

Compares radiation before surgery vs. after surgery for breast cancer.
Aims to improve cancer-free survival and reduce side effects.
For women with high-risk breast cancer who've had chemotherapy.
A large 'Phase 3' study to find the best treatment timing.
You can withdraw at any time without affecting your care.

Who may be eligible?

This study is specifically for women who have been diagnosed with breast cancer that has invaded the breast tissue (not just in the ducts) and affects only one breast. You would need to be planning to have chemotherapy before your surgery and also be recommended for radiation therapy by your doctor.

There are also some general health requirements. You need to be at least 18 years old and generally well enough to go through treatment, meaning you can carry out most of your daily activities without much trouble. The good news is that the type of breast cancer, specifically its hormone or HER2 status, doesn't stop you from joining.

However, you wouldn't be able to participate if you've had radiation therapy to your chest before, if you're pregnant or breastfeeding, or if you have certain existing health conditions like severe heart disease, serious lung problems, or specific connective tissue diseases. It's also not for you if the cancer has spread to other parts of your body, or if you've already had a lot of treatment for your chemotherapy response.

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 with invasive breast cancer in one breast?
Has your doctor recommended chemotherapy before surgery and also radiation therapy?
Are you at least 18 years old and generally healthy?
Have you *not* had radiation therapy to your chest area before?
Are you *not* pregnant or breastfeeding?
Do you *not* have severe heart or lung conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the NeoRad study, you would either receive radiation therapy before your breast cancer surgery, or you would receive it after surgery, which is the current standard approach. The study will carefully monitor your health and how you respond to treatment. This will involve regular check-ups, scans, and possibly blood tests, similar to what you would have during your normal cancer care, but with specific timing related to the study. You'll be followed up over a period to see how you are doing, how long you remain cancer-free, and if you experience any side effects. The exact number of visits and tests will be explained in detail by the study team, and it's important to understand that your care would be carefully supervised throughout.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to medical knowledge that could improve breast cancer treatment for future patients. For you personally, if the radiation before surgery proves more effective, it could lead to a longer period without the cancer returning or fewer long-term side effects. However, as with any medical treatment, there are potential risks, including side effects from radiation therapy, which will be carefully explained to you. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

St. Marien-Krankenhaus Ahaus
Verified postcode
Ahaus, Germany· Recruiting
Hochtaunus-Kliniken
Verified postcode
Bad Homburg, Germany· Recruiting
Sana Klinikum Lichtenberg
Verified postcode
Berlin, Germany· Recruiting
St. Agnes-Hospital
Verified postcode
Bocholt, Germany· Recruiting
Städtisches Klinikum Dessau
Verified postcode
Dessau, Germany· Recruiting
Universitätsfrauenklinik UK OWL, Klinikum Lippe
Verified postcode
Detmold, Germany· Recruiting
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
Verified postcode
Georgsmarienhütte, Germany· Recruiting
Sana Klinikum Hameln-Pyrmont
Verified postcode
Hamelin, Germany· Recruiting
Sana Klinikum Offenbach
Verified postcode
Offenbach, Germany· Recruiting
medius Klinik Ostfildern-Ruit
Verified postcode
Ostfildern, Germany· Recruiting
Leopoldina Krankenhaus Schweinfurt
Verified postcode
Schweinfurt, Germany· Recruiting

Common questions

What is 'preoperative' and 'postoperative' radiotherapy?

Preoperative means receiving radiation therapy before your surgery, while postoperative means receiving it after your surgery.

Why is this study important?

It's important because it aims to find out if there's a better time to give radiation therapy for high-risk breast cancer to improve patient outcomes and reduce side effects.

Will I still get my usual cancer care if I join?

Yes, you will still receive excellent cancer care. The study is comparing two approaches, both of which are carefully monitored and part of your overall treatment plan.

What are the main things the study is looking for?

The study wants to see if one timing of radiation therapy helps patients stay cancer-free for longer and causes fewer long-term side effects.

Can men join this study?

No, this specific study is only for women with breast cancer.

How to find out more

Christiane Matuschek, MD Prof.

christiane.matuschek@uni-bielefeld.de +495215812901 Official trial record

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