Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
NCT ID: NCT07080944
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-12-12
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Patients with SLN visualization.
SLN identification using technetium-99m
SLN Biopsy after pre-surgery positive SLN visualization.
Group 2a
Patients with no pre-surgery SLN visualization and intra-surgery SLN identification.
SLN intra-operatory identification with radioguided surgery
SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.
Group 2b
Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification.
Axillary Limph Node Dissection (ALND)
Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.
Interventions
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SLN identification using technetium-99m
SLN Biopsy after pre-surgery positive SLN visualization.
SLN intra-operatory identification with radioguided surgery
SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.
Axillary Limph Node Dissection (ALND)
Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Locations
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European Institute of Oncology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L2-371
Identifier Type: OTHER
Identifier Source: secondary_id
UID 4964
Identifier Type: -
Identifier Source: org_study_id
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