Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC (SYMPHONY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Breast Carcinoma; Neoadjuvant Chemotherapy; Sentinel Lymph Node Biopsy (SLNB)
• Intervention / Treatment: Procedure: SLN identification using technetium-99m; Procedure: SLN intra-operatory identification with radioguided surgery; Procedure: Axillary Limph Node Dissection (ALND)

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesca Magnoni, MD; Phone Number: +39 0294371092; Email: francesca.magnoni@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Francesca Magnoni, MD; Phone Number: +39 0294371092; Email: francesca.magnoni@ieo.it
    • Principal Investigator: Francesca Magnoni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Patients with SLN visualization.	Procedure: SLN identification using technetium-99m; SLN Biopsy after pre-surgery positive SLN visualization.
Experimental: Group 2a; Patients with no pre-surgery SLN visualization and intra-surgery SLN identification.	Procedure: SLN intra-operatory identification with radioguided surgery; SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.
Active Comparator: Group 2b; Patients with no pre-surgery SLN visualization and no 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: July 15, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UID 4964; L2-371 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No