A trial looking at treatment to the armpit for breast cancer (POSNOC)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

This trial is looking at treatment to the armpit after surgery to remove early stage breast cancer. The trial is for women whose breast cancer has spread to 1 or 2 lymph nodes Open a glossary item.

Doctors usually remove early stage breast cancer with surgery. They will also check the nearby lymph nodes to see if the cancer has started to spread.

If the cancer has started to spread you will have chemotherapy, hormone therapy or both. Currently, you will also have treatment to the lymph nodes in your armpit. This treatment could be more surgery to remove the lymph nodes or radiotherapy Open a glossary item to the lymph nodes. But it isn’t clear if having treatment to the lymph nodes is useful or necessary as drug treatments you will have are more advanced and very good at preventing the cancer from coming back.

In this trial the researchers want to compare women who have treatment to the lymph nodes in their armpit with women who don’t.

The aims of this trial 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 women’s quality of life Open a glossary item

Who can enter

You may be able to join this trial if all of the following apply

You cannot join this trial if any of these apply

  • You have cancer in both your breasts
  • You have had chemotherapy to shrink your cancer before surgery
  • Your cancer has spread to more than 2 nearby lymph nodes
  • Your cancer has spread outside the lymph node into the surrounding tissue  (your doctor can tell you this)
  • You have, or have had, another cancer apart from some early cancers Open a glossary item that have been successfully treated (the trial team can advise you about this)

Trial design

This is a phase 3 trial. The researchers need 1,900 women to join.

After your surgery your doctor may suggest you have further treatment this could be

This is called adjuvant therapy Open a glossary item. Your doctor will talk to you about what may be the best in your case.

In this randomised trial, the women 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.

  • Women in group 1 have adjuvant therapy but no treatment to their armpit after surgery
  • Women in group 2 have adjuvant therapy plus treatment to their armpit after surgery

POSNOC trial diagram

You fill out a few questionnaires before you are randomised to your group and then afterwards at

  • 3 months
  • 6 months
  • 1 year
  • 2 years
  • 3 years

The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study. The researchers will ask you to fill in the first set of questionnaires when you join the trial 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.

Hospital visits

If you have surgery to remove the lymph nodes in your armpit, you will be in hospital for up to 2 days.

If you have radiotherapy to the lymph nodes, you go to the hospital daily, from Monday to Friday, for 3 to 5 weeks. You may not be able to have the radiotherapy at your local hospital so you may need to travel to another hospital for the treatment.

You will be followed up in the outpatient clinic 6 months after you join the study, then at 1 year, and every year after that to 5 years. If you do not have a clinic appointment at that time a member of the trial team at your hospital may contact you by telephone. During follow up, the researchers will check for any signs of cancer coming back and ask you to answer a few questions about problems in your arm and hand.

Side effects

Side effects from having treatment to the armpit can include

  • Long term swelling of the arm (lymphoedema)
  • Stiff sore shoulder
  • Pain or numbness in the arm

Your doctor will talk to you about all the possible side effects of treatment before you agree to take part in the trial.

Location

Aberdeen
Abergavenny
Amersham
Ashington
Bangor
Barnsley
Bath
Bedford
Belfast
Birmingham
Bishop Auckland
Bolton
Boston
Bradford
Bridgend
Brighton
Bristol
Cambridge
Cardiff
Chertsey
Chester
Chesterfield
Crewe
Cumbria
Darlington
Dartford
Derby
Doncaster
Dundee
Dunfermline
Eastbourne
Edinburgh
Exeter
Gillingham
Glasgow
Greenock
Grimsby
Harrogate
Hereford
Hexham
High Wycombe
Hull
Inverness
Kidderminster
Kilmarnock
Kings Lynn
Lancaster
Larbert
Leeds
Leicester
Lincoln
Liverpool
London
Luton
Macclesfield
Maidstone
Manchester
Milton Keynes
Newcastle upon Tyne
Newport
North Shields
Northampton
Norwich
Oxford
Paisley
Peterborough
Plymouth
Poole
Prescot
Redditch
Rhyl
Rhyl
Rotherham
Salford
Scunthorpe
Sheffield
Shrewsbury
Solihull
Southend on Sea
St Albans
St Leonards-on-sea
Stockton-on-Tees
Stoke-on-Trent
Sutton
Sutton Coldfield
Swansea
Swindon
Truro
Warrington
Wirral
Wishaw
Wolverhampton
Worcester
Worthing
Wrexham
Yeovil
Ynysmaerdy

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Amit Goyal

Supported by

Derby Hospital NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
NCRI Radiotherapy Trials QA Group (RTTQA)
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
Nottingham Clinical Trials Unit
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11917

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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