RecruitingNAINTERVENTIONAL

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery

This study is for people with breast cancer that has spread to their armpit lymph nodes. Doctors usually remove many lymph nodes with a surgery called axillary lymph node dissection (ALND). This trial wants to see if a different approach is better. This new approach involves a more focused surgery, called tailored axillary surgery (TAS), followed by radiation therapy (ART) to the armpit. The main goal is to find out if TAS and ART together cause less arm swelling (lymphedema) and lead to a better quality of life regarding arm movement and comfort, compared to the standard ALND surgery, two years after treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

1,060

Start

01 Jan 2026

Estimated completion

01 Dec 2037

Breast Cancer

What is this study about?

When breast cancer spreads, it often goes to the lymph nodes in your armpit. The usual treatment for this is a surgery called axillary lymph node dissection (ALND), which removes many of these lymph nodes. While this surgery is very effective at treating the cancer, it can sometimes lead to issues like arm swelling (lymphedema) and discomfort, which can affect your daily life.

This study is looking into a different approach for treating these lymph nodes. Instead of removing all the affected lymph nodes, researchers are investigating a method called tailored axillary surgery (TAS). This surgery is more precise, removing only the specific lymph nodes that are found to have cancer. After this focused surgery, participants would also receive radiation therapy (ART) to the armpit area. The idea is that removing fewer lymph nodes combined with radiation might still be as effective against the cancer but cause fewer side effects.

The main aim of this trial is to compare these two treatment methods. Researchers want to know if the combination of tailored axillary surgery and radiation therapy (TAS + ART) results in less arm swelling and a better quality of life concerning arm comfort and movement, two years after treatment, compared to the standard axillary lymph node dissection (ALND). Your participation could help improve future treatments for people with breast cancer.

Key takeaways

This study compares standard lymph node surgery with a new surgery plus radiation for breast cancer.
It aims to reduce arm swelling (lymphedema) and improve arm comfort.
Participants will be followed for two years to check their quality of life.
Treatment choices are made randomly, like flipping a coin.
This research could change how breast cancer in the armpit is treated in the future.

Who may be eligible?

This study is for adults, aged 18 or over, who have been diagnosed with breast cancer that has spread to their armpit lymph nodes. This spread must be confirmed by tests, and the cancer should be in certain stages (Stage II or III).

You might be suitable if you are having surgery for the first time for your breast cancer, or if your cancer has come back in the same breast after earlier treatment, provided it's been at least three years and you haven't had previous armpit surgery or radiation. It's important that you are generally well enough for surgery and radiation treatment, and able to fill out questionnaires about your quality of life. For women, it's also important not to be pregnant or planning to become pregnant during the study period.

You would not be able to join the study if your breast cancer is very advanced (Stage IV), or if you have a specific type of advanced lymph node involvement (called N3c without axillary disease). There are other medical conditions that might also mean this study is not right for you, which your doctor would discuss.

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 18 years old or older?
Do you have breast cancer that has spread to your armpit lymph nodes, confirmed by testing?
Are you having surgery for your breast cancer for the first time, or for a recurrence in the same breast after a certain period?
Are you generally well enough for surgery and radiation therapy?
Are you able to fill out questionnaires about your health and arm comfort?
If you are a woman who could become pregnant, are you using effective birth control and not planning pregnancy during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either have the standard lymph node surgery (axillary lymph node dissection) or a more focused surgery followed by radiation therapy to your armpit. The type of treatment you receive will be decided by chance, like flipping a coin. You will have regular check-ups and assessments, including answering questionnaires about your arm comfort and quality of life, for two years after your initial treatment. These questionnaires help the researchers understand the impact of the treatments on your daily life. The total duration of your active participation, including follow-up, will be two years.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a potentially new treatment approach that could lead to fewer long-term side effects like arm swelling, compared to the standard surgery. However, as with any medical trial, there are potential risks, and not all benefits are guaranteed. You might experience side effects from either surgery or radiation therapy. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

Walter Reed National Military Medical Center
Verified postcode
Bethesda, United States· Not yet recruiting
Duke University/Duke Cancer Center
Verified postcode
Durham, United States· Not yet recruiting
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States· Not yet recruiting
Swedish Cancer Institute
Verified postcode
Seattle, United States· Not yet recruiting
KH Dornbirn
Verified postcode
Dornbirn, Austria· Not yet recruiting
LKH Feldkirch
Verified postcode
Feldkirch, Austria· Not yet recruiting
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
Verified postcode
Innsbruck, Austria· Recruiting
Ordensklinikum Linz
Verified postcode
Linz, Austria· Not yet recruiting
Medical University Vienna, Department of Gynecology
Verified postcode
Vienna, Austria· Not yet recruiting
Medical University Vienna, Department of Surgery
Verified postcode
Vienna, Austria· Not yet recruiting
CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal
Verified postcode
Montreal, Canada· Not yet recruiting
Breast Centre of Clinical Hospital, Rijeka
Verified postcode
Rijeka, Croatia· Not yet recruiting

Common questions

What is 'clinically node-positive breast cancer'?

This means that tests have shown your breast cancer has spread to your armpit lymph nodes, and this has been confirmed by your doctor.

What is 'lymphedema'?

Lymphedema is swelling, in this case, in your arm, that can happen after lymph nodes are removed or treated. It's an important issue this study is trying to reduce.

Will I know which treatment I'm getting?

No, whether you receive the standard surgery or the newer combination treatment will be decided by chance, so neither you nor your doctor will get to choose.

How long will I be involved in the study?

You'll be followed up for two years after your treatment to monitor your health and quality of life.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your medical care.

How to find out more

Walter P. Weber, Prof. Dr. med.

walter.weber@usb.ch +41 61 328 61 49 Official trial record

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