AXillary Surgery After NeoAdjuvant Treatment
A Prospective Multicenter Cohort Study to Evaluate Different Surgical Methods of Axillary Staging (sentinel Lymph Node Biopsy, Targeted Axillary Dissection, Axillary Dissection) in Clinically Node-positive Breast Cancer Patients Treated with Neoadjuvant Chemotherapy
European Breast Cancer Research Association of Surgical Trialists
3,000 participants
Apr 28, 2020
OBSERVATIONAL
Conditions
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 Criteria6
- 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 Criteria8
- 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
Locations(1)
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NCT04373655