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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
European Institute of Oncology
RECRUITING
Milan
Contact Information
Primary
Francesca Magnoni, MD
francesca.magnoni@ieo.it
+39 0294371092
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2030-08
Participants
Target number of participants: 75
Treatments
Experimental: Group 1
Patients with SLN visualization.
Experimental: Group 2a
Patients with no pre-surgery SLN visualization and intra-surgery SLN identification.
Active_comparator: Group 2b
Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification.
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov