Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
European Institute of Oncology
75 participants
Dec 12, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 NACT 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
Exclusion Criteria7
- Patients with cN3 stage at diagnosis
- Participants with stage IV (metastatic) breast cancer
- Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained
- Patients with a prior history of ipsilateral breast cancer
- Pregnant patients
- Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging
- Patients not consenting to ALND
Interventions
SLN Biopsy after pre-surgery positive SLN visualization.
SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.
Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.
Locations(1)
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NCT07080944