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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03255577.
PRIMARY OBJECTIVE:
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
Principal InvestigatorAndrea Veronica Barrio
