RecruitingInterventional

Comparing surgical treatments for people with early breast cancer that has spread to the armpit (axillary) lymph nodes: targeted armpit surgery (targeted axillary dissection) versus standard armpit surgery (axillary node clearance)

The TADPOLE study looks at two types of surgery for early breast cancer that has spread to a few lymph nodes in the armpit. Currently, all armpit lymph nodes are often removed, which can lead to problems like arm swelling (lymphoedema) and pain for many patients. This study wants to see if a newer, more focused surgery, called targeted axillary dissection (TAD), is just as safe. TAD involves removing only the affected lymph nodes and the first draining nodes. The aim is to reduce side effects like swelling, while making sure the cancer doesn't come back more often. Participants will be randomly assigned to receive either the standard surgery or the targeted surgery, and their health and well-being will be monitored over several years.

At a glance

Status

Recruiting

Sponsor

North Bristol NHS Trust

Enrolment target

861

Start

01 Oct 2025

Estimated completion

31 Jan 2028

Adults diagnosed with primary T1-2 breast cancer, with low nodal disease

What is this study about?

When breast cancer spreads, it often goes to the lymph nodes in the armpit. The usual treatment for this is an operation to remove all the lymph nodes from the armpit. This is known as an 'axillary node clearance'. While this surgery aims to remove all the cancer, it can cause problems for many patients. About one in three people experience lasting side effects such as swelling in the arm (called lymphoedema), ongoing pain, and difficulties moving their shoulder. These issues can really affect daily life and are expensive for the NHS.

Doctors used to believe removing all the armpit lymph nodes was the best way to stop the cancer from coming back. However, there's not much clear evidence to show this is true when only a small number of lymph nodes are affected. A newer approach, called 'targeted axillary dissection' (TAD), involves removing only the specific lymph nodes that contain cancer cells, along with the very first lymph nodes that drain from the breast (called sentinel nodes).

The TADPOLE study wants to find out if this more targeted surgery (TAD) can reduce the number of patients who get lymphoedema after 12 months, without increasing the chance of the breast cancer returning. By comparing TAD to the standard operation, researchers hope to find a way to treat breast cancer more effectively and with fewer life-changing side effects for patients.

Key takeaways

The TADPOLE study compares two types of armpit surgery for early breast cancer.
It aims to see if a more focused surgery causes fewer side effects like arm swelling and pain.
Participants will be randomly assigned to receive either the standard or targeted surgery.
The study will check if the new surgery is just as safe in preventing cancer recurrence.
Follow-up will last for five years to monitor health and well-being.
This research hopes to improve quality of life for breast cancer patients.

Who may be eligible?

This study is for adults aged 18 or over who have been diagnosed with early breast cancer. Your cancer must be a specific type (T1-2) and you need to have a small number of cancer cells in your armpit lymph nodes – meaning two or fewer lymph nodes are affected. You also need to be fit enough for surgery and willing to take part.

There are certain reasons why you wouldn't be able to join. For example, if you have more than two suspicious lymph nodes, a larger type of cancer (T3 or T4), or a specific kind of breast cancer called 'pure invasive lobular carcinoma'. You also can't take part if you've already had breast cancer on the same side, or if you've had certain treatments like chemotherapy or hormone therapy before surgery. If you've had previous armpit surgery, are pregnant or breastfeeding, or have other serious health conditions that would make participating difficult, you wouldn't be able to join.

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 early breast cancer where only 1 or 2 armpit lymph nodes are affected by cancer?
Are you fit and willing to have surgery?
Have you not had chemotherapy or hormone therapy before your surgery?
Have you not previously had breast cancer on the same side, or any previous armpit surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the TADPOLE study, you'll have some initial health checks, including measurements of your arm. You'll also be asked to fill out questionnaires about your health and quality of life. Once you're in the study, you'll be randomly assigned, like flipping a coin (but with a 2-to-1 chance), to either have the standard armpit surgery or the targeted armpit surgery.

You'll have a hospital visit for a check-up one year after your surgery. For the rest of the follow-up, which lasts five years in total, calls will be made to you at one month, and then at two, three, four, and five years after your operation. During these calls, we'll check your health and other information. You'll also need to complete health questionnaires at one, two, and five years. As part of your usual care, you'll have yearly mammograms for five years. If you're interested, you might also have the chance to be interviewed about your experiences in the study.

Potential risks and benefits

Before deciding, you'll receive a detailed Participant Information Leaflet that explains all the potential benefits and risks of taking part in the TADPOLE study. A potential benefit of taking part is that the targeted surgery (TAD) might lead to fewer side effects like swelling and pain compared to the standard surgery. However, there's also an unknown risk that the targeted surgery might not be as effective at preventing the cancer from returning, which is what the study aims to find out. As with any medical study, you have the right to withdraw at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
United Kingdom

Common questions

What is lymphoedema?

Lymphoedema is long-lasting swelling, usually in the arm, that can happen after surgery to remove lymph nodes in the armpit. It's often caused by damage to the drainage system that removes fluid from the body.

What is the difference between the two surgeries?

The standard surgery (axillary node clearance) removes all the lymph nodes in the armpit. The targeted surgery (targeted axillary dissection, or TAD) only removes the specific lymph nodes that have cancer and the first few draining nodes.

Will I know which surgery I'm getting?

No, you won't know beforehand. You'll be randomly assigned to one of the two surgery groups to ensure the study results are fair and unbiased. Your doctor will know which surgery you had after it's done.

How long will the study run?

The study team expects to enrol patients until about 2028, and then they will follow everyone up until 2033 to gather all the necessary information.

Who is paying for this study?

The study is funded by the National Institute for Health and Social Care Research (NIHR), which is a major UK-based funder of health research.

How to find out more

Lucy Dabner

Tadpole-trial@bristol.ac.uk +44 0117 45 51524 Official trial record

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