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Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

NCT07080944 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2030-07-31
Completion
2030-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080944 on ClinicalTrials.gov