NCT07080944

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
51mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Dec 2025Aug 2030

First Submitted

Initial submission to the registry

July 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 12, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

July 15, 2025

Last Update Submit

January 2, 2026

Conditions

Sentinel Lymph Node Biopsy (SLNB)Neoadjuvant ChemotherapyInvasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Disease-free survival (DFS)

    5 years.

  • Distant recurrence-free survival (DRFS)

    5 years

  • Breast cancer-specific survival (BCSS)

    5 years

  • Overall survival (OS)

    5 years

Study Arms (3)

Group 1

EXPERIMENTAL

Patients with SLN visualization.

Procedure: SLN identification using technetium-99m

Group 2a

EXPERIMENTAL

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

Procedure: SLN intra-operatory identification with radioguided surgery

Group 2b

ACTIVE COMPARATOR

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

Procedure: Axillary Limph Node Dissection (ALND)

Interventions

SLN identification using technetium-99mPROCEDURE

SLN Biopsy after pre-surgery positive SLN visualization.

Group 1
SLN intra-operatory identification with radioguided surgeryPROCEDURE

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

Group 2a
Axillary Limph Node Dissection (ALND)PROCEDURE

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

Group 2b

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

Central Study Contacts

Francesca Magnoni, MD

CONTACT

+39 0294371092francesca.magnoni@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 23, 2025

Study Start

December 12, 2025

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

IT(1)