Active not recruitingNAINTERVENTIONAL

POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

The POSNOC study is for women with early breast cancer where the cancer has spread to one or two lymph nodes in the armpit. Normally, these women would have these lymph nodes removed or receive radiotherapy to the armpit, in addition to their standard drug treatments. This study wants to find out if giving only the standard drug treatments (like chemotherapy or hormone therapy) is just as good, in terms of preventing the cancer from coming back in the armpit within five years, as having drug treatments *plus* armpit surgery or radiotherapy. It's hoped that if this is true, some women could avoid unnecessary extra treatments and their side effects.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Enrolment target

1,900

Start

01 Aug 2014

Estimated completion

31 Dec 2026

Breast Cancer

What is this study about?

When breast cancer spreads, it often goes to the lymph nodes in your armpit first. If you have early breast cancer and doctors find one or two tiny spots of cancer in these armpit lymph nodes, the usual approach is to remove more lymph nodes from the armpit (a surgery called axillary node clearance) or give radiotherapy to the armpit. This is on top of other treatments like chemotherapy, hormone therapy, or radiotherapy to the breast.

However, these extra armpit treatments can sometimes cause side effects, such as swelling in the arm (lymphedema) or shoulder stiffness. The POSNOC study is trying to understand if these extra armpit treatments are always necessary for women with only one or two affected lymph nodes. The study compares giving only the standard drug treatments to giving the standard drug treatments *plus* the extra armpit treatments, to see if there's any difference in how well the cancer is controlled in the armpit.

The aim is to see if skipping these additional armpit treatments makes no difference to your outcome over five years. If this is shown to be true, it could mean that many women in the future might be able to avoid these extra procedures and their potential side effects, while still getting the best possible care for their breast cancer. All women in the study will receive standard drug treatments designed to fight the cancer throughout their body.

Key takeaways

The study helps decide if less treatment to the armpit is safe for some women.
It's for women with early breast cancer and one or two affected armpit lymph nodes.
All participants will receive standard drug treatments for breast cancer.
You'll be monitored closely for five years.
This research could help future patients avoid unnecessary side effects.

Who may be eligible?

This study is for women who have been diagnosed with early breast cancer. Your tumour should be no larger than 5cm. Crucially, the cancer should have spread to only one or two lymph nodes in your armpit, and these spots of cancer in the lymph nodes must be a certain size (doctors call this a 'macrometastasis'). You'll also need to be well enough to have all the treatments involved in the study.

You would not be able to join if you have cancer in both breasts, or if more than two of your armpit lymph nodes are affected. If you've already had some specific treatments for breast cancer, like chemotherapy before your surgery (neo-adjuvant therapy), or previous surgery to your armpit for the same breast, you might not be suitable. Also, if you've had another type of cancer recently, you might not be able to take part.

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.

Do you have early breast cancer?
Is your breast tumour 5cm or smaller?
Have cancer cells been found in only one or two of your armpit lymph nodes?
Are you well enough for cancer treatment?
Have you *not* had chemotherapy for this breast cancer before surgery?

Answer every question to see your result.

What does participation involve?

If you join the POSNOC study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive standard drug treatments (such as chemotherapy, hormone therapy, or targeted therapy) for your breast cancer, along with possible radiotherapy to your breast or chest wall. The other group will receive these same standard drug treatments and breast/chest wall radiotherapy, *plus* additional treatment to your armpit, which could be surgery to remove more lymph nodes or radiotherapy to the armpit area.

All participants will have regular check-ups and follow-up appointments. You'll be followed closely by the study team for five years after your initial treatment. This is to monitor your health and see how well the treatments are working. The specific schedule of visits and tests will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in the study means you might receive a treatment approach that could potentially reduce the number of surgeries or radiotherapy sessions you need, and therefore reduce the risk of side effects like arm swelling. However, there's also a chance that skipping the extra armpit treatment might not be as effective in controlling the cancer in the armpit for everyone. All medical treatments carry risks, and the study team will explain these in detail. You are free to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (50)

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

Royal Adelaide Hospital
Verified postcode
Adelaide, Australia
Bankstown-Lidcocombe Hospital
Verified postcode
Bankstown, Australia
Maeter Hospital
Verified postcode
Brisbane, Australia
Coffs Harbour Health Campus
Verified postcode
Coffs Harbour, Australia
Monash Cancer Centre
Verified postcode
Melbourne, Australia
Royal Melbourne and Royal Women's Hospital
Verified postcode
Melbourne, Australia
Sir Charles Gairdner Hospital
Verified postcode
Perth, Australia
Riverina Cancer Care Centre
Verified postcode
Wagga Wagga, Australia
Waikato Hospital
Verified postcode
Hamilton, New Zealand
Rotorua Hospital
Verified postcode
Rotorua, New Zealand
Ashford and St Peter's Hospitals NHS Foundation Trust
Verified postcode
Ashford, United Kingdom
Barnsley Hospital
Verified postcode
Barnsley, United Kingdom

Common questions

What does 'early breast cancer' mean?

It means the breast cancer is still contained within the breast or has only spread a very short distance to nearby lymph nodes, often before it has become widely established.

What are lymph nodes and why are they important?

Lymph nodes are small, bean-shaped glands that are part of your body's immune system. Cancer cells can sometimes spread from the breast to these nodes, especially those in the armpit, where they can be detected.

What is 'standard drug treatment'?

This usually refers to medicines like chemotherapy (to kill cancer cells), hormone therapy (to block hormones that fuel certain breast cancers), or targeted therapies, depending on your specific type of cancer.

Will I know which treatment group I'm in?

Yes, you will know if you are assigned to receive just the drug treatment or if you will also have additional armpit surgery/radiotherapy.

What happens after the five-year follow-up?

After five years, your participation in the study's specific follow-up will end, and your ongoing care will return to your standard NHS follow-up with your specialist team.