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Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC

ConditionsInvasive Breast CarcinomaSentinel Lymph Node Biopsy (SLNB)Neoadjuvant Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SLN identification using technetium-99m

    Procedure/Surgery

    SLN Biopsy after pre-surgery positive SLN visualization.

  • SLN intra-operatory identification with radioguided surgery

    Procedure/Surgery

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

  • Axillary Limph Node Dissection (ALND)

    Procedure/Surgery

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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2aExperimental treatment 1 intervention
Group C: Group 2bActive comparator 1 intervention

Trial outcomes

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.

Time frame
3 Months

Secondary outcomes

1

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.
2

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
3

Breast cancer-specific survival (BCSS)

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

Time frame
5 years
4

Overall survival (OS)

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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