The TADPOLE Study logo

Patient information

The TADPOLE Study

A UK research study comparing two ways of doing armpit (axillary) surgery for people with early breast cancer.

  • Focuses on arm swelling and shoulder problems after surgery.
  • Checks that a more targeted operation is as safe as standard surgery.
  • Designed with patients and breast cancer specialists.
Thinking about joining the study? See what would happen
Important: This website gives general information. Only your own hospital team can tell you if TADPOLE is suitable for you.
Illustration of a woman learning about her armpit surgery in TADPOLE

Watch: armpit surgery in TADPOLE explained

The TADPOLE animation walks you through what is happening in your armpit, the two types of surgery included in the study, and what taking part would involve.

  • Created with breast cancer specialists and patient input.
  • Explains unfamiliar terms in plain language.
  • Helps you prepare questions for your surgical team.

Prefer reading instead? Scroll down for a step-by-step explanation.

Is this study for me?

You may hear about TADPOLE from your breast surgeon or breast care nurse if your situation is similar to the one below.

Your breast cancer

You have early breast cancer in one breast, and scans or biopsies show a small amount of cancer in one or two armpit lymph nodes.

Your treatment plan

You are having surgery as your first treatment for breast cancer (before any chemotherapy or hormone treatment).

Where you are treated

You are being treated at an NHS hospital taking part in TADPOLE. The research nurse or doctor there will talk you through whether the study might be right for you.

If you have questions, email or call the TADPOLE team — our contact details are here.
Diagram showing breast tumour, lymph nodes and how cancer can spread

What is happening in my armpit?

Lymph nodes are small glands that help your body fight infections. They are connected by thin lymph vessels and act a little like filters.

In some people with early breast cancer, cancer cells travel from the tumour in the breast to the lymph nodes in the armpit (the axilla).

The sentinel lymph nodes are the first nodes that lymph fluid drains to from the breast. If cancer has spread, it often reaches these nodes first.

Surgeons look at the lymph nodes to see whether cancer has spread and to decide what further treatment you may need.

Two types of armpit surgery in this study

Everyone in TADPOLE has breast surgery. The study compares two safe and widely used ways of removing lymph nodes from the armpit.

Standard surgery – ANC

Axillary node clearance

Illustration showing all armpit lymph nodes cleared
  • Most or all lymph nodes in the armpit are removed.
  • Very effective at clearing cancer from the armpit.
  • Higher chance of long-term arm swelling and shoulder problems for some people.

Targeted surgery – TAD

Targeted axillary dissection

Illustration showing an extra ultrasound scan and injection Illustration showing comparison between ANC and TAD
  • Just the affected nodes and the first draining (“sentinel”) nodes are removed.
  • You have one extra ultrasound scan to locate the target nodes.
  • You have one extra injection to help your surgeon find the nodes during surgery.
  • May lower the chance of arm swelling – this is what the study is testing.

How is the type of surgery decided in the study?

In TADPOLE, a computer allocates people by chance to ANC or TAD. This is called randomisation.

ANC
TAD

More people are placed in the TAD group than the ANC group so that we can learn more quickly about the newer, targeted surgery. Neither you nor your doctors can choose your group.

Study progress

TADPOLE is being carried out across the UK. The numbers below are updated by the central trial team from time to time.

People who have joined TADPOLE

122

People who have completed follow-up

74

Hospitals taking part

24

These figures are for information only and are not updated in real time.

Where is the study running?

TADPOLE is open, or preparing to open, in a number of NHS hospitals across the UK. Your breast team can tell you whether your hospital is one of them.

The map shows participating hospitals. You can zoom in and click on a site to see more detail.

Map provided by the central TADPOLE team via Google Maps.

What would taking part involve?

Here is a simple overview of what usually happens if you decide to join TADPOLE.

  1. Talk to your team

    Your surgeon or research nurse explains the study, answers your questions and gives you written information to take home.

  2. Decide and give consent

    You choose whether to join. If you decide to take part, you sign a consent form. You can change your mind at any time.

  3. Pre-surgery checks

    Before your operation, we measure your arm and ask you to fill in short questionnaires about your symptoms and quality of life.

  4. Randomisation

    A computer allocates you by chance to ANC or TAD. You then have breast and armpit surgery as planned.

  5. Usual cancer treatment

    After surgery you have any recommended treatments, such as radiotherapy, chemotherapy or hormone therapy.

  6. Follow-up

    We keep in touch for up to five years to see how your arm is doing, how you are feeling and how your cancer treatment has gone.

Your questions answered

Do I have to take part?

No. Joining the study is your choice. If you decide not to take part, you will still receive the best standard care available.

Will saying no affect my care?

No. Your decision will not affect how your doctors and nurses look after you now or in the future.

What are the risks?

Both ANC and TAD are established operations. All surgery has risks such as bleeding, infection and stiffness. ANC removes more lymph nodes and is linked with a higher risk of arm swelling. TAD removes fewer nodes; the study checks that this is as safe for cancer control.

How is my information used?

Your hospital team collects information from your medical records and sends coded data to the Bristol Trials Centre. Data are stored securely and results are reported so that no individual is identified.

Can I change my mind later?

Yes. You can withdraw from the study at any time without giving a reason. Your team will discuss what happens to information already collected about you.

How will I hear about the results?

When the study is finished we will publish the results in medical journals and share a plain-language summary on this website. You can also choose to receive a summary directly.

Downloads & further information

These documents are similar to the information you may be given in clinic. Your local team will give you the versions that apply to your hospital.

Participant information leaflet

A detailed leaflet explaining the study in full.

Download PDF

Additional study information

More detail about how the study is run and what is measured.

Full Information

Study pathway

A visual overview of the visits and follow-up in TADPOLE.

Download PDF

If you need these in large print, audio or another language, please ask your local research team.

Who runs the TADPOLE Study?

  • Chief Investigator: Professor Shelley Potter
  • Sponsor: North Bristol NHS Trust
  • Trial coordination: Bristol Trials Centre, University of Bristol
  • Funder: National Institute for Health and Care Research (NIHR) Health Technology Assessment programme

Approvals & oversight

The study has been reviewed by a Research Ethics Committee and the Health Research Authority. It is registered on a public trials registry. Regulators and auditors may look at study data to check that it is being run safely and correctly.

This website gives general information and does not replace advice from your own healthcare team.