RecruitingNot ApplicableNCT07080944

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

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


Sponsor

European Institute of Oncology

Enrollment

75 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a procedure called sentinel lymph node biopsy — where a small number of lymph nodes are removed and tested — can accurately assess whether cancer has cleared from the lymph nodes after chemotherapy in women with inflammatory breast cancer (IBC), a rare and aggressive type that initially causes redness, swelling, and skin changes rather than a lump. **You may be eligible if...** - You are a woman over 18 with biopsy-confirmed inflammatory breast cancer (Stage IIIB) - You have completed chemotherapy before surgery and imaging shows no remaining cancer in the lymph nodes - You are willing and able to follow the study procedures **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (Stage IV) - You had cancer in both armpits at diagnosis - You have had prior breast cancer on the same side - You are pregnant - You still have palpable (felt by hand) or imaging-visible cancer in the lymph nodes after chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESLN identification using technetium-99m

SLN Biopsy after pre-surgery positive SLN visualization.

PROCEDURESLN intra-operatory identification with radioguided surgery

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

PROCEDUREAxillary Limph Node Dissection (ALND)

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


Locations(1)

European Institute of Oncology

Milan, Italy

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NCT07080944


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