AXillary Surgery After NeoAdjuvant Treatment
Recruiting · NCT04373655 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
The optimal surgical axillary staging technique in patients who convert from the clinically positive to clinically negative lymph node status under neoadjuvant therapy (cN+ → ycN0) remains to be clarified. Different strategies (axillary lymph node dissection, sentinel node biopsy, targeted axillary dissection) are currently used in different countries. A prospective analysis comparing these techniques regarding feasibility, safety, morbidity and surgical effort is urgently needed. Due to high complexity and discordant recommendations, a randomized trial comparing different techniques is hardly feasible. Therefore, the EUBREAST study group decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy.
Who can take part
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 is running
1 location listed.
- Klinikum Esslingen - Esslingen am Neckar, Germany