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Recruiting NCT04373655

AXillary Surgery After NeoAdjuvant Treatment

Conditions: Breast Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3000
Sponsor: European Breast Cancer Research Association of Surgical Trialists

Location: Klinikum Esslingen Esslingen am Neckar

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 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04373655). StuddyBuddy aggregates publicly available trial information.