Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC (NCT07080944) | Clinical Trial Compass
RecruitingNot Applicable
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
Italy75 participantsStarted 2025-12-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.