Clinical trial · Interventional
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Chemotherapy | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Limph Node Dissection (ALND) | Procedure | — | UNRESOLVED |
| SLN identification using technetium-99m | Procedure | — | UNRESOLVED |
| SLN intra-operatory identification with radioguided surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Patients with SLN visualization.
- interventionNames
- Procedure: SLN identification using technetium-99m
- type
- EXPERIMENTAL
- label
- Group 2a
- description
- Patients with no pre-surgery SLN visualization and intra-surgery SLN identification.
- interventionNames
- Procedure: SLN intra-operatory identification with radioguided surgery
- type
- ACTIVE_COMPARATOR
- label
- Group 2b
- description
- Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
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