Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
Recruiting · NCT07080944 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Axillary Limph Node Dissection (ALND)SLN identification using technetium-99mSLN intra-operatory identification with radioguided surgery
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- European Institute of Oncology - Milan, Italy