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AXillary Surgery After NeoAdjuvant Treatment

Study acronym: AXSANA
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Eligibility criteria expanded, about 14 words
    • Study description revised
    • Publications: details revised at 3 of 3 entries
  2. Re-verified, no change to tracked fieldsv6
  3. Study sites: 9 to 1
    • Collaborators: 5 to 6
    • Eligibility criteria shortened, about 4 words
    v5
  4. Study sites: 6 to 9v4
  5. Study sites: 1 to 6v3
  6. Collaborators: 4 to 5v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04373655
Lead Sponsor European Breast Cancer Research Association of Surgical Trialists
Collaborators: AWOgyn, AGO-B, North Eastern German Society of Gynaecological Oncology, GBG Forschungs GmbH, Claudia von Schilling Foundation for Breast Cancer Research, Ehmann-Stiftung Savognin
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov