Actively Recruiting
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
Led by European Institute of Oncology · Updated on 2026-01-06
75
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin/chest wall involvement (cT4d) and heavy nodal burden at presentation (cN1/N2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.
CONDITIONS
Official Title
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging
- Patients receiving neoadjuvant chemotherapy and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)
- Ability to understand and willingness to sign informed consent document and comply with study procedures
You will not qualify if you...
- Patients with cN3 stage at diagnosis
- Participants with stage IV (metastatic) breast cancer
- Participants with positive contralateral axillary nodes identified on standard imaging studies and cytologically confirmed
- Patients with a prior history of ipsilateral breast cancer
- Pregnant patients
- Patients after neoadjuvant chemotherapy with persistent palpable axillary nodes or persistent pathological axillary nodes as assessed by imaging
- Patients not consenting to axillary lymph node dissection
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
F
Francesca Magnoni, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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