AXillary Surgery After NeoAdjuvant Treatment
NCT04373655
Summary
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.
Eligibility
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
Conditions2
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT04373655