Active not recruitingNAINTERVENTIONAL

Axillary Node Dissection Versus no Dissection in Breast Cancer With Positive Sentinel Lymph Node

This study aims to discover if it's safe to avoid a second armpit surgery (called axillary node dissection) in women with certain types of early breast cancer. Currently, if the first lymph node removed (sentinel node) contains cancer cells, a second, more extensive surgery is often performed. Previous studies suggest that skipping this second surgery might not significantly impact how well patients do, but more definitive research is needed. This new trial wants to confirm if avoiding this extra surgery is just as good for patients. If proven safe, it could mean shorter hospital stays, fewer side effects from surgery, and a quicker recovery for many women.

At a glance

Status

Active not recruiting

Phase

Sponsor

Institut Paoli-Calmettes

Enrolment target

2,228

Start

19 Jul 2012

Estimated completion

01 Sep 2031

Invasive Breast Cancer

What is this study about?

When breast cancer is found, doctors sometimes remove a few lymph nodes from the armpit, called sentinel lymph nodes, to see if the cancer has spread. If these nodes contain cancer cells, it's often recommended to remove more lymph nodes in a surgery called an axillary node dissection. This is done to check for more cancer cells and help guide further treatment.

However, some smaller studies have hinted that for certain women with early breast cancer, skipping this second, more extensive armpit surgery might not make much difference to their recovery or how long they stay cancer-free. But doctors need much stronger evidence before they can confidently change their usual approach. They want to make sure it's just as safe and effective for patients.

This study is a large, new trial designed to provide that stronger evidence. It will compare women who have the standard second armpit surgery with those who don't, to see if there are any differences in their health and well-being over time. The aim is to find out if avoiding this second surgery is a safe option, which could lead to fewer side effects like swelling in the arm (lymphoedema), shorter hospital stays, and quicker recovery times for many women with breast cancer.

Key takeaways

This study is for women with early breast cancer where cancer cells are found in the sentinel lymph node.
It compares standard armpit surgery with not having that surgery.
The goal is to see if skipping the second surgery is safe and effective.
It could potentially lead to fewer side effects and quicker recovery for patients.
Participation involves being randomly assigned to one of two treatment groups.

Who may be eligible?

This study is looking for women aged 18 or older who have been recently diagnosed with invasive breast cancer. You would be considered if your cancer is in one spot in the breast and is up to 5cm in size, and if you haven't yet received treatment like chemotherapy or hormone therapy for this cancer. Doctors also need to confirm that the cancer hasn't visibly spread to other parts of your body or to the lymph nodes in your armpit.

To join, a special technique called a sentinel lymph node biopsy must be suitable for you, and it must show that some cancer cells are present in those nodes. You can't have had breast cancer before (either in the same breast or the other one) or any other invasive cancer in the past, except for certain skin cancers that have been fully treated.

You also can't be pregnant, breastfeeding, or planning to become pregnant. If you have any other serious medical problems, or conditions that might make surgery difficult, you might not be able to take part. It's important to discuss all your health history with your doctor to see if this study is right for you.

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?
Have you been diagnosed with invasive breast cancer that's up to 5cm, and you haven't started treatment yet?
Has your sentinel lymph node biopsy shown some cancer cells?
Have you *not* had breast cancer before, or any other serious cancer?
Are you *not* pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have your breast cancer surgery as planned. After your sentinel lymph nodes are checked during surgery and found to contain cancer cells, you would then be randomly assigned to one of two groups: either you will have the standard additional armpit surgery (axillary dissection) or you will not. You won't get to choose which group you're in, as this is decided by chance, like flipping a coin. This helps ensure the study results are fair.

After your surgery, doctors will regularly monitor your health and recovery over a period of time. This will involve follow-up appointments and possibly scans or tests, similar to what you would have after standard breast cancer treatment. The exact schedule of visits and tests will be explained to you in detail by the study team. The total duration of your participation will depend on the study's follow-up plan, which could be several years.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping doctors understand the best treatment approach for women with your type of breast cancer. If avoiding the additional armpit surgery proves to be safe and effective, it could mean you avoid potential complications linked to that surgery, such as arm swelling (lymphoedema), numbness, or infection. However, there's also a chance that not having the additional surgery could be less effective for you, though the study is designed to carefully monitor for this. The potential risks of any surgery and standard cancer treatment will still apply. You also have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Gilles HOUVENAEGHEL, PHD
Verified postcode
Marseille, France

Common questions

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. They can sometimes be where cancer cells spread first, so doctors check them to understand how far the cancer has progressed.

What is a 'sentinel lymph node'?

The sentinel lymph node is usually the first lymph node or group of nodes that cancer cells would reach if they spread from the breast. Doctors find and remove it to check for cancer without taking out all the nodes.

What is 'axillary node dissection'?

This is a surgery to remove more lymph nodes from your armpit (axilla). It's done if cancer cells are found in the sentinel lymph node, to make sure all affected nodes are removed.

Will I still get treatment if I don't have the second surgery?

Yes, regardless of your study group, you will receive appropriate breast cancer treatment, which may include surgery on the breast itself and other treatments like chemotherapy, radiotherapy, or hormone therapy, as recommended by your doctors.

Who is funding this study?

The information provided does not specify the funding source, but clinical trials are typically funded by government health agencies, research foundations, or pharmaceutical companies.