NCT07080944

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Breast Carcinoma
• Sentinel Lymph Node Biopsy (SLNB)
• Neoadjuvant Chemotherapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-12
• Primary completion: 2030-07-01
• Completion: 2030-08-01
• First posted: 2025-07-23
• Last updated: 2026-01-06

Locations

1 site across 1 country: Italy