Status:
RECRUITING
AXillary Surgery After NeoAdjuvant Treatment
Lead Sponsor:
European Breast Cancer Research Association of Surgical Trialists
Collaborating Sponsors:
AWOgyn
AGO-B
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 clari...
Detailed Description
For many decades, axillary lymph node dissection (ALND) has been considered standard of care in breast cancer (BC) patients. The procedure aimed at assessing the pN status to guide adjuvant therapy de...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04373655
Start Date
April 28 2020
End Date
April 1 2030
Last Update
March 3 2025
Active Locations (1)
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1
Klinikum Esslingen
Esslingen am Neckar, Germany