Evaluating lymph node biopsy accuracy after chemotherapy for advanced 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 study aims to assess the accuracy of the sentinel lymph node biopsy (SLNB) procedure in detecting residual cancer cells in patients with locally advanced breast cancer who have undergone neoadjuvant chemotherapy. Female patients over 18 years with biopsy-proven breast cancer and specific clinical characteristics will be included. The study will involve surgical intervention to perform SLNB and evaluate its effectiveness in identifying remaining cancer post-chemotherapy. The findings could help refine treatment approaches for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients over 18 years of age with biopsy-proven breast cancer
* Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging
* Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies
* Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam

Exclusion Criteria:

* Patients with a prior history of ipsilateral breast cancer
* Pregnant patients
* Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam
* Patients not consenting to ALND

Where it's running

• BAPTIST ALLIANCE - MCI (Data Collection Only)
  Miami, Florida, United States Recruiting
• Memorial Sloan Kettering at Basking Ridge (Consent and Follow Up)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent only and Follow Up)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Commack
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester
  Harrison, New York, United States Recruiting

Study contacts

• Principal investigator: Andrea Barrio, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Andrea Barrio, MD
• Email: barrioa@mskcc.org
• Phone: 646-888-5117

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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.