Active not recruitingNAINTERVENTIONAL

Omission of SLNB in Triple-negative and HER2-positive Breast Cancer Patients With rCR and pCR in the Breast After NAST

This study is investigating if certain breast cancer patients can safely avoid surgery to remove lymph nodes from their armpit. It's for women with an aggressive type of breast cancer (triple-negative or HER2-positive) who have had a very good response to chemotherapy before their main breast surgery. The researchers want to see if, when chemotherapy completely clears away the cancer in the breast and armpit area, this additional lymph node surgery is still necessary. Avoiding this surgery could mean fewer side effects and a quicker recovery for patients. The study aims to gather evidence quickly from 350 patients across Europe to see if this change in treatment approach is safe and effective.

At a glance

Status

Active not recruiting

Phase

Sponsor

Toralf Reimer, MD PhD

Enrolment target

350

Start

13 Jan 2021

Estimated completion

01 Jan 2028

Breast Cancer Female Breast Cancer

What is this study about?

This study, called EUBREAST-01, is exploring a new way to treat certain types of breast cancer. Normally, after finding breast cancer, doctors often check the lymph nodes in the armpit to see if the cancer has spread there. This usually involves a surgery called a sentinel lymph node biopsy (SLNB).

However, for some aggressive types of breast cancer, like triple-negative or HER2-positive, chemotherapy given before surgery (called 'neoadjuvant systemic therapy' or NAST) can be so effective that it completely clears the cancer from the breast and sometimes the lymph nodes. If the cancer is completely gone, the doctors are asking if the armpit lymph node surgery is still needed. Avoiding this extra surgery could mean patients have fewer complications, such as swelling in the arm (lymphoedema), and a faster recovery.

This study will involve 350 patients across several European countries. It's designed to quickly find out if it's safe to skip the armpit lymph node surgery entirely for patients who have these specific types of breast cancer and who have had a complete clear-out of their cancer in the breast and armpit after their chemotherapy. The results could potentially change how these patients are treated in the future, making the treatment pathway less invasive.

Key takeaways

This study explores avoiding armpit lymph node surgery for specific breast cancer types.
It's for women with triple-negative or HER2-positive breast cancer.
Patients must have a complete response to chemotherapy before surgery.
The goal is to reduce side effects and improve recovery.
Follow-up involves regular check-ups for up to seven years.
This could change future treatment plans for these patients.

Who may be eligible?

This study is for women who have recently been diagnosed with a specific type of breast cancer. You would be considered if you have triple-negative or HER2-positive breast cancer that has not spread beyond the breast or armpit, and your original tumour was not too large (T1-T3). You must also have started chemotherapy for your breast cancer.

Crucially, after your chemotherapy, scans must show that the cancer in your breast has completely gone, and you should be planning to have surgery that removes only part of your breast (a lumpectomy) followed by radiotherapy to the whole breast. You also need to be at least 18 years old and able to commit to the follow-up appointments required by the study.

However, you would not be able to join if you've had other cancers in the past five years (except certain skin or cervical cancers), if your chemotherapy ended more than three months ago, if you're pregnant or breastfeeding, or if you're planning a full mastectomy (removal of the whole breast) after chemotherapy. Men are also not eligible for this particular study.

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 a woman aged 18 or older with breast cancer?
Do you have triple-negative or HER2-positive breast cancer?
Has your cancer not spread beyond the breast or armpit?
Did your chemotherapy completely clear the cancer from your breast on scans?
Are you planning to have breast-conserving surgery (lumpectomy) and radiotherapy?
Have you not had other cancers in the last 5 years (except certain skin or cervical cancers)?

Answer every question to see your result.

What does participation involve?

If you join this study, your treatment will involve standard chemotherapy for your breast cancer, followed by a lumpectomy (breast-conserving surgery) and radiotherapy. The main difference is that if your chemotherapy completely clears your cancer from the breast and armpit area, you will not have the standard armpit lymph node surgery (sentinel lymph node biopsy).

You will have regular check-ups with your medical team. For the first three years after your surgery, you'll have an appointment every six months. After that, you'll have yearly check-ups until seven years have passed since your surgery. These appointments will include a physical examination, and you'll have annual mammograms and ultrasound scans. Other tests will be done if your doctor thinks they are needed based on your symptoms. There are no additional medications specifically for this study.

Potential risks and benefits

A potential benefit of joining this study is that you might avoid armpit lymph node surgery, which could lead to fewer side effects like swelling in the arm (lymphoedema), numbness, or pain. The study aims to confirm if this approach is safe and as effective as current standard care. However, there's always a small chance that undetected cancer cells could remain in the lymph nodes, which is why close follow-up is essential. As with any clinical trial, there might be unknown risks, and your doctor will discuss these with you. You are free to withdraw from the study at any time without affecting your standard medical care.

Locations (40)

Med. Universität Graz, Frauenklinik
Verified postcode
Graz, Austria
Praxis Dres. Heinrich & Bangerter
Verified postcode
Augsburg, Germany
Universitäts-Klinikum, Frauenklinik
Verified postcode
Augsburg, Germany
Klinikum Mittelbaden Brustzentrum
Verified postcode
Baden-Baden, Germany
DRK Kliniken Köpenick, Brustzentrum
Verified postcode
Berlin, Germany
Evang. Waldkrankenhaus Spandau, Brustzentrum
Verified postcode
Berlin, Germany
Sana Klinikum Lichtenberg
Verified postcode
Berlin, Germany
Augusta-Klinik Brustzentrum
Verified postcode
Bochum, Germany
Brustzentrum Nordsachsen, Frauenklinik
Verified postcode
Borna, Germany
Marienhospital, Klinik für Gynäkologie
Verified postcode
Bottrop, Germany
Kreiskliniken Böblingen, Frauenklinik
Verified postcode
Böblingen, Germany
Carl-Thiem-Klinikum, Frauenklinik
Verified postcode
Cottbus, Germany

Common questions

What kind of breast cancer is this study for?

It's for triple-negative or HER2-positive breast cancer, which are specific types that often respond very well to chemotherapy.

What does 'omission of SLNB' mean?

It means skipping the surgery to remove lymph nodes from your armpit. 'SLNB' stands for sentinel lymph node biopsy.

What is 'NAST'?

NAST stands for Neoadjuvant Systemic Therapy, which is chemotherapy given before breast cancer surgery.

Will I still have surgery if I join this study?

Yes, you will still have surgery to remove the tumour from your breast (a lumpectomy), but you might avoid the armpit lymph node surgery.

How long will I be followed up in this study?

You'll be followed for at least three years, with the longest follow-up being seven years, through regular check-ups and scans.