Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
This study is for people with early-stage breast cancer where cancer cells were found in their armpit lymph nodes, but these cells disappeared after chemotherapy. Usually, these patients would have more surgery (axillary lymph node dissection) or radiation (axillary radiotherapy) to their armpit. However, these treatments can cause side effects like arm swelling (lymphoedema). We want to find out if avoiding these extra treatments is just as effective at keeping the cancer away, but causes fewer side effects. Patients in the study will either receive the standard armpit treatment or no further armpit treatment, and we'll compare their health over five years.
At a glance
What is this study about?
When someone has early-stage breast cancer, doctors often check the lymph nodes in their armpit (called the axilla) to see if the cancer has spread. If cancer cells are found there, patients usually receive chemotherapy before surgery. This chemotherapy aims to shrink or even completely remove the cancer, both in the breast and in the lymph nodes.
After chemotherapy, if tests show that the cancer cells in the armpit lymph nodes are gone, doctors typically still recommend further treatment for the armpit, either by removing more lymph nodes (a surgery called axillary lymph node dissection) or by giving radiation therapy to the armpit. While these treatments are effective, they can sometimes cause problems like swelling in the arm (lymphoedema), stiffness, pain, and numbness because they can damage the drainage system in the arm.
This study wants to explore if these extra armpit treatments are always necessary for patients whose armpit lymph nodes are clear after chemotherapy. We believe that for these specific patients, it might be possible to skip the additional armpit surgery or radiation, leading to fewer side effects like lymphoedema, without increasing the risk of the cancer coming back. The study will compare patients who receive the usual armpit treatment with those who don't, to see which approach offers the best balance of effectiveness and fewer long-term side effects.
Key takeaways
- This study evaluates if extra armpit treatment is needed after chemotherapy for specific breast cancer patients.
- It aims to reduce side effects like arm swelling (lymphoedema).
- Patients are already free of cancer in their armpit lymph nodes after chemotherapy.
- The study compares standard armpit treatment with no additional armpit treatment.
- Results will assess cancer return rates and quality of life over five years.
Who may be eligible?
This study is looking for adults aged 18 or older, both men and women, who have been diagnosed with early-stage breast cancer. A key point is that cancer must have been found in the lymph nodes in your armpit through a needle biopsy before you started chemotherapy. After finishing your chemotherapy, tests must show that there are no remaining cancer cells in your armpit lymph nodes.
Also, doctors will need to have removed at least three lymph nodes during a special procedure called a sentinel node biopsy, and these must not show any signs of cancer. You will have received standard chemotherapy treatment for your cancer, and other aspects of your treatment, like any hormone therapy or targeted therapy, will follow usual local guidelines. If you had cancer in your armpit nodes but no obvious cancer in the breast itself, you might still be eligible.
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.
- Are you 18 years old or older?
- Was cancer found in your armpit lymph nodes by needle biopsy before chemotherapy?
- After chemotherapy, did your armpit lymph nodes show no signs of cancer?
- Have you had at least three lymph nodes removed during a sentinel node biopsy, and they are clear?
- Did you receive standard chemotherapy for your breast cancer?
What does participation involve?
If you join this study, your journey will be somewhat similar to standard breast cancer treatment. Everyone will receive treatments for their breast or chest wall, which might include targeted therapy, hormone therapy, and radiation, as guided by your local hospital. What differs is the treatment for your armpit.
You will be randomly assigned to one of two groups. One group will receive the standard armpit treatment, which means you might have more lymph nodes removed or receive radiation to your armpit. The other group will not receive these extra armpit treatments. Regardless of your group, you’ll have regular check-ups and assessments to monitor your health and recovery over a period of five years. The total duration of active follow-up for the study is five years.
Potential risks and benefits
Locations (98)
- St Vincent's University Hospital - St Vincent's Healthcare GroupVerified postcodeDublin, Ireland· Recruiting
- St Luke's Hospital - St Luke's Radiation Oncology NetworkVerified postcodeDublin, Ireland· Recruiting
- Beaumont Hospital - Royal College of Surgeons in IrelandVerified postcodeDublin, Ireland· Recruiting
- Galway University Hospitals - Saolta University Health Care GroupVerified postcodeGalway, Ireland· Recruiting
- Airedale General Hospital - Airedale NHS Foundation TrustVerified postcodeKeighley, United Kingdom· Recruiting
- Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation TrustVerified postcodeCarlisle, United Kingdom· Recruiting
- Frimley Park Hospital - Frimley Health NHS Foundation TrustVerified postcodeCamberley, United Kingdom· Recruiting
- Raigmore Hospital - NHS HighlandVerified postcodeInverness, United Kingdom· Recruiting
- James Paget Hospital -James Paget University Hospitals NHS Foundation TrustVerified postcodeGreat Yarmouth, United Kingdom· Recruiting
- Royal Berkshire Hospital - Royal Berkshire NHS Foundation TrustVerified postcodeReading, United Kingdom· Recruiting
- Macclesfield District General Hospital - East Cheshire NHS TrustVerified postcodeMacclesfield, United Kingdom· Recruiting
- Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS TrustVerified postcodeShrewsbury, United Kingdom· Recruiting
Common questions
What is a sentinel lymph node biopsy?
It's a procedure to find and remove the first few lymph nodes that cancer cells might spread to from a tumour. If these 'sentinel' nodes are clear, it often means the cancer hasn't spread further.
What is neoadjuvant chemotherapy?
This is chemotherapy given before breast cancer surgery. It's used to shrink the tumour and any cancer in the lymph nodes, making surgery potentially easier and more effective.
What is lymphoedema?
Lymphoedema is swelling that can occur in an arm or leg, often after lymph nodes have been removed or damaged during cancer treatment. It happens when fluid can't drain away properly.
Will I know which treatment group I'm in?
Yes, this is an 'open' study, meaning both you and your medical team will know whether you are receiving the standard armpit treatment or no further armpit treatment.
What does 'non-inferior' mean?
In this study, it means we want to see if avoiding armpit treatment isn't significantly worse than standard treatment at keeping the cancer away, while also hopefully reducing side effects.
How to find out more
Amit Goyal, MS, MD, FRCS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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