NCT07080944 Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC
| NCT ID | NCT07080944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Invasive Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2025-12-12 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07080944 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Invasive Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07080944 currently recruiting?
Yes, NCT07080944 is actively recruiting participants. Contact the research team at francesca.magnoni@ieo.it for enrollment information.
Where is the NCT07080944 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07080944 clinical trial?
NCT07080944 is sponsored by European Institute of Oncology. The trial plans to enroll 75 participants.