Sentinel lymph node biopsy after neoadjuvant chemotherapy for inflammatory breast cancer
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial
NA · European Institute of Oncology · NCT07080944
This trial will test whether sentinel lymph node biopsy after preoperative chemotherapy is feasible and safe for people with inflammatory breast cancer who initially had extensive lymph node involvement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT07080944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged over 18 with biopsy-confirmed inflammatory breast cancer (cT4d cN0-2 M0) who receive neoadjuvant chemotherapy and convert to clinically node-negative status, and who agree to axillary dissection and follow-up, are appropriate candidates.
Not a fit: Patients with cN3 disease, metastatic (stage IV) cancer, persistent clinical or imaging evidence of axillary disease after chemotherapy, prior ipsilateral breast cancer, pregnancy, or those who refuse ALND are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could allow some patients to avoid more extensive axillary surgery and reduce complications like lymphedema.
How similar studies have performed: Sentinel node biopsy after neoadjuvant chemotherapy has been shown feasible in non-inflammatory locally advanced breast cancer—especially with dual-tracer and targeted node techniques—but its application to inflammatory breast cancer using single-tracer mapping is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesca Magnoni, MD
- Email: francesca.magnoni@ieo.it
- Phone: +39 0294371092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Invasive Breast Carcinoma, Sentinel Lymph Node Biopsy, Neoadjuvant Chemotherapy