Patients who have breast cancer that has spread to lymph glands on needle biopsy often have neoadjuvant chemotherapy (a type of chemotherapy that acts to shrink the cancer cells before patients have their operation). We now know that neoadjuvant chemotherapy can completely get rid of the cancer cells in the lymph glands in around 40% to 70% of patients. Currently, these patients with no remaining cancer in their lymph glands, have armpit treatment. This treatment could be surgery to remove the lymph nodes or radiotherapy to the armpit and can have side effects such as swelling of the arm, shoulder stiffness, and numbness or pain in the arm or hand.

It isn’t clear if having treatment to the lymph nodes is useful or necessary. In this study the researchers want to compare patients who have treatment to the lymph nodes in their armpit with patients who don’t.

The aims of this study are to find out

• If treatment to the lymph nodes in the armpit is necessary

• More about the side effects of having treatment to the lymph nodes in the armpit

• How treatment to the lymph nodes in the armpit affects patient’s quality of life

You can join this study if all of the following apply:

• • You have early stage breast cancer and needle biopsy has confirmed spread to the lymph gland in your armpit

  • You have neoadjuvant chemotherapy treatment to shrink your cancer before you have your surgery

  • You are at least 18 years old

  • Your cancer has not spread to the skin or chest wall

You cannot join this study if any of the following apply:

• • You have invasive cancer in both of your breasts

  • You have had surgery to the armpit on the cancerous side previously

Your doctor will discuss the study and give written study information to you so that you can consider whether you would like to join the study. You can take this information home and discuss it with family before reaching a decision. If you choose to take part in the study, you will be asked to sign a consent form.

You can enter the study 1) before surgery or 2) after surgery.

Participants entering the study before surgery

You will be entered into this study in two stages: the registration stage and the randomisation stage. The study has a two-step entry process to ensure that patients entering the main randomised study are eligible.

Registration stage

You will be registered to the study before your breast surgery. During your breast surgery, your surgeon will do a procedure called sentinel node biopsy, to check how well the neoadjuvant chemotherapy has shrunk the cancer in your armpit. This is done by removing at least three lymph glands from your armpit and these will be tested for cancer cells.

If your sentinel node biopsy shows that there are still signs of cancer in the lymph glands of your armpit, you will not be entered into the randomised study - you will instead continue with routine treatment to the armpit. You will still continue as a registered participant within the study, and we will collect routine information about your future health status.

Randomisation stage

If your sentinel lymph node biopsy shows that there are no signs of cancer left in your lymph glands, then you are eligible to take part in main randomised study.

Participants entering the study after surgery

You can join the study after surgery if sentinel lymph node biopsy shows that there are no signs of cancer left in your lymph glands. All participants entering the study here will take part in the main randomised study.

Randomised study

Participants taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

• • Participants in group 1 have no further treatment to their armpit after surgery

  • Participants in group 2 have further treatment to their armpit after surgery. This will either be surgery to remove the remaining lymph glands or treated with radiotherapy.

You fill out a few questionnaires when you are randomised to your group and then afterwards at 1 year, 2 years, 3 years, 4 years, 5 years.

The questionnaires will ask about side effects and how you’ve been feeling. The researchers will ask you to fill in the first set of questionnaires when you join the randomised study at one of your clinic appointments. They will post the following questionnaires to you to fill at home and return in the prepaid envelope provided.

ALL patients taking part in the study, whichever group they are in, will continue to receive all other treatments prescribed for them. This depends on the type of breast cancer they have. These might include hormone therapy (usually tablets) and radiotherapy to the breast or chest wall. The randomisation is just for the treatment of the armpit, the axilla.

We do not know whether armpit treatment has any effect on the chance of your cancer coming back. That is why we are doing this study.

You will have regular examinations, regardless of which group you are in, to check if the cancer is coming back. Your doctor will discuss with you the best course of action if you are found to have armpit recurrence.

We cannot promise the study will help you. But information we get from the study will help improve future care for patients with early breast cancer that has spread to one or two lymph glands.

Axillary management in T1-3N1M0 breast cancer patients with needle biopsy proven nodal metastases at presentation after NEoadjuvant Chemotherapy.

This is a UK-wide trial. In order to join the trial you will need to discuss it with your treating doctor or breast care nurse.