Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SLN identification using technetium-99m, SLN intra-operatory identification with radioguided surgery, Axillary Limph Node Dissection (ALND).
- Who it may be relevant to
- Registry conditions: Invasive Breast Carcinoma, Sentinel Lymph Node Biopsy (SLNB), Neoadjuvant Chemotherapy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
Overview
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.
Interventions
- Procedure SLN identification using technetium-99m
SLN Biopsy after pre-surgery positive SLN visualization. - Procedure SLN intra-operatory identification with radioguided surgery
SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification. - Procedure 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.
Primary outcome measures
- intraoperative SLN identification rate. [Time frame: 3 Months]
Secondary outcome measures (4)
- Disease-free survival (DFS) [Time frame: 5 years.]
- Distant recurrence-free survival (DRFS) [Time frame: 5 years]
- Breast cancer-specific survival (BCSS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Identifiers
NCT: NCT07080944 · UID 4964 · L2-371