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

European Institute of Oncology

Status: Enrolling

Conditions: Invasive Breast Carcinoma; Neoadjuvant Chemotherapy; Sentinel Lymph Node Biopsy (SLNB)

Treatments: Procedure: SLN intra-operatory identification with radioguided surgery; Procedure: Axillary Limph Node Dissection (ALND); Procedure: SLN identification using technetium-99m

Study type: Interventional

Funder types: Other

Identifiers

NCT07080944

L2-371 (Other Identifier)

UID 4964

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Group 1

Experimental group

Description:

Patients with SLN visualization.

Treatment:

Procedure: SLN identification using technetium-99m

Group 2a

Experimental group

Description:

Patients with no pre-surgery SLN visualization and intra-surgery SLN identification.

Treatment:

Procedure: SLN intra-operatory identification with radioguided surgery

Group 2b

Active Comparator group

Description:

Patients with no pre-surgery SLN visualization and no intra-surgery SLN identification.

Treatment:

Procedure: Axillary Limph Node Dissection (ALND)