RecruitingOBSERVATIONAL

TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes

This study is investigating a new surgical technique called Targeted Axillary Dissection (TAD) for patients with breast cancer that has spread to three or more lymph nodes in the armpit before treatment. Many patients have chemotherapy first, which can clear cancer from these nodes altogether. Normally, a bigger surgery (Axillary Lymph Node Dissection or ALND) is used, but this can cause unwanted side effects. TAD is a less invasive option. The study wants to find out if TAD is as good as ALND at finding any remaining affected lymph nodes in these specific patients. This is important because knowing if all cancer is gone helps doctors plan the best next steps and potentially avoid a more extensive operation.

At a glance

Status

Recruiting

Sponsor

Kliniken Essen-Mitte

Enrolment target

150

Start

07 Mar 2022

Estimated completion

01 Mar 2032

Breast Cancer Node-positive Breast Cancer

What is this study about?

When breast cancer spreads to the underarm lymph nodes, doctors often suggest a chemotherapy treatment first, before surgery. For many patients, this chemotherapy is very effective, and can completely clear the cancer from both the breast and the lymph nodes. When this happens, doctors are keen to use less intense surgical methods because the traditional, more extensive surgery (called Axillary Lymph Node Dissection or ALND) can lead to uncomfortable side effects like swelling in the arm.

This study is focused on a newer, less invasive surgical approach called Targeted Axillary Dissection (TAD). For patients whose cancer initially affected three or more lymph nodes, it's particularly important to know if TAD can reliably find any remaining cancer cells in those nodes after chemotherapy. If TAD misses any affected nodes, it could mean some cancer is left behind, which isn't good. However, if it's accurate, it could spare many patients from a more demanding operation.

The main goal of this research is to compare TAD with the traditional ALND in these specific group of patients (those with three or more suspicious lymph nodes originally). By doing both procedures, doctors can see how often TAD correctly identifies all affected nodes (or confirms they are clear) compared to the ALND. This will help them understand if TAD is a safe and effective option for more patients in the future, potentially leading to easier recoveries and better quality of life.

Key takeaways

This study is for people with breast cancer that has spread to three or more lymph nodes in the armpit.
It aims to see if a less invasive surgery (TAD) is as effective as a more extensive one (ALND) after chemotherapy.
Participation involves your regular cancer treatment, with doctors gathering information from it.
The goal is to improve future treatment for breast cancer patients, potentially reducing surgical side effects.
You will receive both types of surgery (TAD and ALND) as part of your standard care.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 or older) with invasive breast cancer that your doctor has confirmed has spread to at least three lymph nodes in your armpit. Importantly, these specific lymph nodes would have been marked by your medical team before you started any chemotherapy. You must be planned to receive chemotherapy and then a specific type of surgery that includes both TAD and ALND. The study is for those who haven't had previous major breast or armpit surgery, radiation to the area, or cancer that has spread to other parts of the body.

You would not be able to join if your breast cancer has not spread to at least three lymph nodes, or if you aren't planned to have chemotherapy. People who have already started their cancer treatment before hearing about the study, or those with certain types of breast cancer like inflammatory breast cancer, would also not be able to participate. You must also be able to understand the study and follow its instructions.

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?
Has your doctor confirmed your cancer has spread to at least 3 lymph nodes in your armpit?
Were these specific lymph nodes marked before you started chemotherapy?
Are you scheduled to have chemotherapy before surgery?
Are you planned to have both TAD and ALND as part of your surgery?

Answer every question to see your result.

What does participation involve?

This study is a registry study, meaning it collects information from your routine medical care. If you qualify and choose to participate, you will have your usual diagnostic tests and treatments as recommended by your doctors. Before you start chemotherapy, the suspicious lymph nodes in your armpit will be marked (for example, with a small clip). After your chemotherapy, you will have both a Targeted Axillary Dissection (TAD) and an Axillary Lymph Node Dissection (ALND) as part of your surgery. Doctors will then compare the results from the nodes removed by both methods. Your participation primarily involves allowing your medical information from these procedures to be collected and analyzed for the study. There are no extra visits or experimental medications beyond your standard care. The total duration would cover the period from your diagnosis through your initial surgical treatment.

Potential risks and benefits

A potential benefit of this study is that it may help doctors understand if a less invasive surgery (TAD) is safe and effective for patients with many affected lymph nodes at diagnosis. This could lead to fewer side effects like arm swelling for future patients. However, for you as an individual, the study involves receiving both the TAD and the more extensive ALND, so you will still experience the recovery associated with the more traditional surgery. There are no direct medical risks from participating beyond those inherent to your standard treatment. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Kliniken Essen-Mitte (KEM)
Verified postcode
Essen, Germany· Recruiting

Common questions

What are lymph nodes and why are they important in breast cancer?

Lymph nodes are small, bean-shaped glands that are part of your immune system. Doctors check them in breast cancer to see if cancer cells have spread, which helps decide the best treatment plan.

What is chemotherapy and why would I have it before surgery?

Chemotherapy is a strong medicine designed to kill cancer cells throughout your body. Having it before surgery can shrink the tumor and clear cancer from lymph nodes, sometimes making surgery less extensive.

What's the difference between TAD and ALND?

ALND is a traditional surgery that removes many lymph nodes from your armpit. TAD is a newer, less invasive technique that aims to only remove the specific lymph nodes that were suspicious before treatment, plus a few 'sentinel' nodes, with the goal of fewer side effects.

Why is this study looking at patients with many suspicious lymph nodes?

Most studies of TAD have focused on patients with fewer affected nodes. This study is important because it's looking specifically at patients with three or more suspicious nodes to see if TAD is accurate enough for them, potentially saving them from a larger operation.

Will participating in this study change my treatment plan?

Your treatment plan, including chemotherapy and the surgeries (TAD and ALND), is already planned as part of your standard care. The study aims to gather information from these treatments; it won't change what your doctors recommend for you.

How to find out more

Oliver Halfmann

o.halfmann@kem-med.com +49201174 Official trial record

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