“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A trial looking at treatment to the armpit for breast cancer (POSNOC)
More about this trial
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 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
Who can enter
You may be able to join this trial if all of the following apply
- You are a woman with breast cancer and are having surgery to remove it
- Your cancer measures no more than 5cm across (early stage breast cancer)
- Your cancer has spread to 1 or 2 of the nearest lymph nodes
- You are having chemotherapy or hormone therapy or both after your surgery
- You are at least 18 years old
You cannot join this trial if any of these apply
- You have invasive cancer in both your breasts
- You have had chemotherapy to shrink your cancer before surgery, unless if you had surgery to the armpit to check for cancer spread before starting chemotherapy
- Your cancer has spread to more than 2 nearby lymph nodes
- You have, or have had, another cancer in the last 5 years, apart from some early cancers that have been successfully treated (the trial team can advise you about this)
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. 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
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.
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 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.
How to join a clinical trial
Associate Professor Amit Goyal
Derby Teaching Hospital NHS Foundation Trust
Australia and New Zealand Breast Cancer Trials Group (ANZBCTG)
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)