Evaluating surgical techniques for breast cancer after neoadjuvant treatment
Official title: A Prospective Multicenter Cohort Study to Evaluate Different Surgical Methods of Axillary Staging (Sentinel Lymph Node Biopsy, Targeted Axillary Dissection, Axillary Dissection) in Clinically Node-positive Breast Cancer Patients Treated With Neoadjuvant Chemotherapy
Run by European Breast Cancer Research Association of Surgical Trialists · NCT04373655 · Data updated 2026-11-12
This study is testing different surgical methods for breast cancer patients who have had chemotherapy to see which one is safer and works best for checking lymph nodes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | European Breast Cancer Research Association of Surgical Trialists Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Esslingen am Neckar) |
| Status | Recruiting |
| Started | April 28, 2020 |
| Main results expected | April 2030 |
| Study ends | April 2030 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT04373655 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with primary invasive breast cancer who are clinically node-positive and scheduled for neoadjuvant systemic therapy.
✕Probably not a fit
Patients with distant metastasis, recurrent breast cancer, or those unsuitable for surgical treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare different surgical techniques for axillary staging in breast cancer patients who have transitioned from clinically positive to negative lymph node status following neoadjuvant chemotherapy. It will analyze the feasibility, safety, morbidity, and surgical effort associated with axillary lymph node dissection, sentinel lymph node biopsy, and targeted axillary dissection. Given the complexity and varying recommendations, a prospective cohort study is being conducted internationally to gather comparative data on these techniques. The findings could help refine surgical approaches and improve patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less invasive surgical options for breast cancer patients, potentially improving their quality of life.
How similar studies have gone: While there have been studies addressing axillary staging techniques, this study's specific focus on patients transitioning from cN+ to ycN0 after neoadjuvant therapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent form * Primary invasive breast cancer (confirmed by core biopsy) * cN+ * cT1-4c * Scheduled for neoadjuvant systemic therapy * Female / male patients ≥ 18 years old Exclusion criteria * Distant metastasis * Recurrent breast cancer * Inflammatory breast cancer * Extramammary breast cancer * Supraclavicular lymph node metastasis * Pregnancy * Less than 4 cycles of NACT administered * Patients not suitable for surgical treatment
Where it's running
-
Klinikum Esslingen
Esslingen am Neckar, Germany Recruiting
Study contacts
- Study coordinator: Thorsten Kühn, Prof.
- Email: info@eubreast.com
- Phone: +49711 3103-3051
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.