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