All studies
CompletedPhase IIIInterventional

A randomized trial of armpit (axilla) treatment for women with early stage breast cancer. POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy.

When women have surgery for early breast cancer, doctors check the lymph glands in the armpit to see if cancer has spread. If cancer cells are found in one or two glands, traditional treatment involves more armpit surgery or armpit radiotherapy. While effective, these extra treatments can cause long-term problems, including arm swelling (lymphoedema) and shoulder stiffness. Today, almost all women also receive whole-body drug treatments after surgery, such as hormone tablets, chemotherapy, or targeted medicines. Doctors believe these medicines might destroy any remaining cancer cells on their own. The POSNOC study compares giving standard drug therapy alone against drug therapy plus extra armpit surgery or radiotherapy. The main aim is to find out if women can safely avoid extra armpit procedures, reducing unwanted side effects while keeping their cancer treatment just as effective.

At a glance

Status
Completed
Phase
Phase III
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Enrolment target
1,900
Start
01 Jan 2014
Estimated completion
13 Jul 2021

What is this study about?

During surgery for early-stage breast cancer, surgeons usually remove and test the first few lymph glands in the armpit (known as sentinel nodes). Lymph glands filter fluid and help fight infection, but they are also the first place breast cancer can spread. In the past, finding even a small amount of cancer in these glands meant a woman would need further surgery to clear out most armpit glands, or radiotherapy to the whole armpit area.

While extra armpit treatments help remove cancer cells, they can lead to uncomfortable, long-term problems. The most common is lymphoedema, an ongoing swelling in the arm and hand that can be painful and hard to manage. It can also cause numbness and restricted shoulder movement.

Most women with early breast cancer now receive modern drug therapies—such as hormone tablets, chemotherapy, or targeted drugs. These medicines travel throughout the entire body to seek out and destroy stray cancer cells. Specialists think these drugs may already deal with small amounts of cancer left in the armpit, making extra armpit surgery or radiotherapy unnecessary.

The POSNOC trial was designed to test this question safely. By comparing women who have drug treatment alone with women who have drug treatment plus armpit surgery or radiotherapy, researchers hope to confirm whether extra armpit treatment can be safely left out without increasing the chance of cancer returning.

Key takeaways

  • Tests whether extra armpit surgery or radiotherapy is really needed for early breast cancer with 1 or 2 positive glands.
  • Aims to reduce the risk of long-term complications like arm swelling (lymphoedema).
  • All patients receive standard drug treatments like hormone therapy or chemotherapy.
  • Participants are randomly assigned to either drug therapy alone or drug therapy plus extra armpit treatment.
  • Taking part is completely voluntary and does not affect your right to standard NHS care.

Who may be eligible?

This study is open to women aged 18 and over who have been diagnosed with early-stage invasive breast cancer. The main breast tumour must measure 5 centimetres or less across. Participants must also be well enough to undergo standard cancer treatments.

To be eligible, tests on the armpit lymph glands removed during initial surgery must show small amounts of cancer in only one or two glands.

Women cannot take part if they have cancer in both breasts, if cancer is found in three or more lymph glands, or if they have previously had surgery in that same armpit. Certain treatments given before surgery may also make someone ineligible.

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.

  1. I am a woman aged 18 or over.
  2. I have early-stage breast cancer with a tumour measuring 5 cm or less.
  3. Tests showed cancer in only 1 or 2 of my armpit lymph glands.
  4. I have not had previous surgery on the same armpit.
  5. I am fit enough to receive standard breast cancer drug treatments.
Answer every question to see your result.

What does participation involve?

If you decide to join the study, a computer will place you into one of two treatment groups by chance (at random). One group receives standard drug treatments (such as hormone therapy or chemotherapy) with no further treatment to the armpit. The other group receives the same drug treatments, plus extra treatment to the armpit—either surgery to clear the remaining lymph glands or radiotherapy to the area. You will attend regular hospital appointments so your doctors can examine your arm, check your general health, and manage any side effects. You will also be asked to fill out short questionnaires about your daily life and arm movement. Follow-up takes place over several years, closely matching regular NHS breast cancer review visits.

Potential risks and benefits

Taking part may not directly improve your personal health, but your results will help doctors understand how to spare future patients from unnecessary surgery or radiotherapy. If you are in the group that does not receive extra armpit treatment, you may have a lower chance of developing painful arm swelling (lymphoedema) and stiffness. However, there is a very small possibility of cancer returning in the armpit. If you receive extra armpit treatment, you face the common side effects of surgery or radiotherapy. Joining the study is entirely your choice, and you can leave at any time without your standard NHS care or relationship with your medical team being affected.

Locations (1)

  • Royal Derby Hospital
    Approximate
    Derby, England

Common questions

What is the main question this trial is trying to answer?

It aims to find out if standard cancer drug treatments alone are enough to treat the armpit when only one or two lymph glands contain cancer cells.

Can I choose which treatment group I go into?

No. A computer assigns you to a group by chance. This makes the trial fair and ensures the results are scientifically reliable.

What is lymphoedema?

Lymphoedema is a long-lasting swelling of the arm, hand, or chest that can happen when lymph glands are removed or treated with radiotherapy.

Will I still receive standard breast cancer care?

Yes. All participants receive standard breast surgery and recommended drug therapies, such as chemotherapy, hormone therapy, or targeted drugs.

What happens if I change my mind after joining?

You are free to stop participating at any time. Your doctors will simply discuss your options and continue giving you the best standard treatment.

How to find out more

Mickey Lewis

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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