Evaluating surgical techniques for breast cancer after neoadjuvant treatment
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
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Breast Cancer Research Association of Surgical Trialists Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Esslingen am Neckar) |
| Trial ID | NCT04373655 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with distant metastasis, recurrent breast cancer, or those unsuitable for surgical treatment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Esslingen am Neckar
- Klinikum Esslingen — Esslingen am Neckar, Germany (Recruiting)
Study contacts
- Study coordinator: Thorsten Kühn, Prof.
- Email: info@eubreast.com
- Phone: +49711 3103-3051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.