Sentinel lymph node biopsy after neoadjuvant chemotherapy for inflammatory breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center study at the European Institute of Oncology enrolls women with biopsy-proven inflammatory breast cancer (cT4d cN0-2 M0) who receive neoadjuvant chemotherapy and convert to clinically node-negative (ycN0). After chemotherapy, single-tracer technetium-99m mapping and radioguided surgery will be used to identify sentinel lymph nodes. Patients will undergo axillary lymph node dissection to confirm nodal pathology and to determine the sentinel node identification rate and immediate oncologic safety. Participants will be followed long-term for recurrence and survival to define the outcomes of this approach in this high-risk population.

Why it matters

Who can join: the full rules

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's running

• European Institute of Oncology
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Francesca Magnoni, MD
• Email: francesca.magnoni@ieo.it
• Phone: +39 0294371092

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.