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Sentinel Lymph Node Biopsy after Chemotherapy before Surgery in Identifying Residual Cancer Cells in Patients with Locally Advanced Breast Cancer
Trial Status: active
This clinical trial studies how well sentinel lymph node biopsy after chemotherapy before surgery works in identifying residual cancer cells in patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Sentinel lymph node biopsy is the removal and examination of the sentinel node(s) (the first lymph node[s] to which cancer cells are likely to spread from a primary tumor) and may help to allow patients with breast cancer to have fewer lymph nodes removed as part of their cancer care in the future.
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 axillary lymph node dissection (ALND)
Additional locations may be listed on ClinicalTrials.gov for NCT03255577.
Locations matching your search criteria
United States
Florida
Miami
Advanced Medical Specialties-Miami Cancer Institute
I. To prospectively determine the false-negative rate (FNR) of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NAC) in locally advanced breast cancer patients traditionally considered ineligible for post-treatment SLNB due to heavy nodal burden at presentation (cN2/N3) or locally advanced cancer with skin/chest wall involvement (cT4).
SECONDARY OBJECTIVES:
I. To assess the sentinel lymph node identification rate after NAC using dual tracer mapping with technetium Tc-99m sulfur colloid (technetium-99m sulfur colloid) and isosulfan blue (lymphazurin blue) dye in patients presenting with locally advanced breast cancer.
II. To determine the frequency with which 3 or more sentinel lymph nodes are obtained at the time of SLNB in locally advanced breast cancer (LABC) patients after NAC.
OUTLINE:
Patients receive technetium Tc-99m sulfur colloid intradermally (ID) on day before or day of surgery. Patients also receive isosulfan blue subareolarly and then undergo sentinel lymph node biopsy on day of surgery.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
