AXillary Surgery After NeoAdjuvant Treatment
This international study is for people with breast cancer whose lymph nodes, which were initially affected, appear clear after chemotherapy. Doctors want to find the best surgical method to check these lymph nodes. They are comparing different ways surgeons remove lymph nodes – like removing several (axillary lymph node dissection), removing just a few key ones (sentinel node biopsy), or removing specific marked ones (targeted axillary dissection). The main goal is to understand which of these approaches is most effective, safest, causes the fewest problems for patients, and is easiest for surgeons. Because there are different recommendations around the world, this study helps gather information to find a clearer best practice.
At a glance
What is this study about?
When you have breast cancer, doctors often check your lymph nodes in the armpit to see if the cancer has spread. Sometimes, chemotherapy is given before surgery to shrink the tumour and any cancer cells in the lymph nodes. This is called neoadjuvant therapy. For some patients, the cancer in their lymph nodes, which was originally noticed, can no longer be seen after this treatment.
However, it's still very important to know for sure if all the cancer cells are gone from these lymph nodes. There are different ways surgeons do this, like removing all the lymph nodes in the armpit, removing just a few key 'sentinel' lymph nodes, or targeting and removing specific lymph nodes that were marked before treatment. Currently, doctors in different countries use different methods, and there isn't a clear agreement on which one is best in this specific situation.
This study aims to compare these different surgical techniques. It will look at how well each method works, whether it's safe, how many problems or side effects it might cause, and how difficult it is for the surgeon. By gathering information from many patients around the world, researchers hope to find out which way is the most effective and has the fewest downsides for people like you.
Key takeaways
- This study helps doctors find the best way to check lymph nodes after chemotherapy for breast cancer.
- It compares different surgical methods to see which is safest and works best.
- You won't get new treatments; the study observes your standard care.
- It's for people with breast cancer whose lymph nodes appear clear after chemotherapy.
- Your participation helps improve future breast cancer treatments for others.
- You can stop participating at any time without affecting your medical care.
Who may be eligible?
This study is looking for both men and women, aged 18 or older, who have been diagnosed with a type of breast cancer that has spread to their lymph nodes. They must be planning to have chemotherapy treatment before their surgery for breast cancer.
You would not be able to join the study if your cancer has already spread to other parts of your body far away from the breast (called distant metastasis), or if your breast cancer has come back after previous treatment. Also, if you have a specific type of breast cancer called inflammatory breast cancer or if you are pregnant, you won't be able to take part.
Other reasons you might not be eligible include if you have cancer in your collarbone (supraclavicular) lymph nodes, if you've had less than four cycles of chemotherapy, or if you're not well enough to have surgery.
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?
- Do you have invasive breast cancer that was in your lymph nodes?
- Are you planning to have chemotherapy before breast cancer surgery?
- Has your cancer not spread to distant parts of your body?
- Are you not pregnant or breastfeeding?
- Are you generally well enough for surgery?
What does participation involve?
This study is an observational study, which means you won't be given a new medicine or treatment. Instead, doctors will observe and record information about the standard care you receive. You'll undergo your planned breast cancer treatment, including chemotherapy before surgery. During your surgery, your medical team will use one of the existing methods to check your lymph nodes, such as removing all of them, removing a few 'sentinel' ones, or removing marked ones. Your doctors will decide which method is best for you, based on current practice.
The study will then collect information about your surgery, any side effects you experience, and the results of your lymph node check. There aren't specific extra visits or tests for the study beyond your usual medical appointments. The total duration of your participation would cover your treatment and follow-up as determined by your medical team.
Potential risks and benefits
Locations (1)
- Klinikum EsslingenVerified postcodeEsslingen am Neckar, Germany· Recruiting
Common questions
What is 'neoadjuvant therapy'?
It's chemotherapy given before surgery to shrink the breast cancer tumour and any cancer cells in the lymph nodes.
What does cN+ mean?
It means that before treatment, cancer cells were found in the lymph nodes near the breast.
Will my treatment change if I join this study?
No, your doctors will continue to give you the standard care and treatment they believe is best for you. The study simply collects information about that care.
Will I have extra tests or appointments?
Generally no. The study uses information from your regular medical appointments and treatments.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without it affecting your medical care in any way.
How to find out more
Thorsten Kühn, Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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