Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

European Institute of Oncology75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 Months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 5 years

Breast cancer-specific survival (BCSS)

BCSS will be defined as the time from surgery to death due to breast cancer.

Time frame: 5 years

Overall survival (OS)

OS will be defined as the time from surgery to death from any cause.

Time frame: 5 years

Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts