Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

NCT ID: NCT07080944

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-12

Study Completion Date

2030-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Patients with SLN visualization.

Group Type EXPERIMENTAL

SLN identification using technetium-99m

Intervention Type PROCEDURE

SLN Biopsy after pre-surgery positive SLN visualization.

Group 2a

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

Group Type EXPERIMENTAL

SLN intra-operatory identification with radioguided surgery

Intervention Type PROCEDURE

SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.

Group 2b

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

Group Type ACTIVE_COMPARATOR

Axillary Limph Node Dissection (ALND)

Intervention Type PROCEDURE

Axillary Limph Node Dissection (ALND) after no pre-surgery SLN visualization using technetium-99m and no intra-surgery SLN identification.

Interventions

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SLN identification using technetium-99m

SLN Biopsy after pre-surgery positive SLN visualization.

Intervention Type PROCEDURE

SLN intra-operatory identification with radioguided surgery

SLN biopsy after no pre-surgery SLN visualization using technetium-99m and intra-surgery SLN identification.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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European Institute of Oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesca Magnoni, MD

Role: CONTACT

+39 0294371092

Facility Contacts

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Francesca Magnoni, MD

Role: primary

+39 0294371092

Other Identifiers

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L2-371

Identifier Type: OTHER

Identifier Source: secondary_id

UID 4964

Identifier Type: -

Identifier Source: org_study_id

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