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| ID | Type | Description | Link |
|---|---|---|---|
| L2-371 | Other Identifier | Comitato Etico Territoriale Lombardia 2 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients with SLN visualization. |
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| Group 2a | Experimental | Patients with no pre-surgery SLN visualization and intra-surgery SLN identification. |
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| Group 2b | Active Comparator | Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLN identification using technetium-99m | Procedure | SLN Biopsy after pre-surgery positive SLN visualization. |
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| Measure | Description | Time Frame |
|---|---|---|
| intraoperative SLN identification rate. | Evaluation of the feasibility of SLNB in a selected cohort of IBC patients operated who responded to systemic NACT in the axillary nodes, achieving complete clinical response (ycN0). The feasibility of SLNB, defined as the intraoperative SLN identification rate, will be calculated as the proportion of patients with successfully identified intraoperative SLNs among the enrolled patients. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | DFS will be defined as the time from surgery to loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death, whichever occurs first. | 5 years. |
| Distant recurrence-free survival (DRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Magnoni, MD | Contact | +39 0294371092 | francesca.magnoni@ieo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
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| SLN intra-operatory identification with radioguided surgery | Procedure | SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification. |
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| Axillary Limph Node Dissection (ALND) | Procedure | Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification. |
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DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.
| 5 years |
| Breast cancer-specific survival (BCSS) | BCSS will be defined as the time from surgery to death due to breast cancer. | 5 years |
| Overall survival (OS) | OS will be defined as the time from surgery to death from any cause. | 5 years |