Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
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
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
Treatments tested in this trial
- SLN identification using technetium-99m
- SLN intra-operatory identification with radioguided surgery
- Axillary Limph Node Dissection (ALND)
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov