Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer
- Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node
status after neoadjuvant therapy in women with stage II, III, or IV breast cancer.
- Correlate gene expression profiling of the primary breast cancer with axillary and
sentinel lymph node status in these patients.
OUTLINE: This is a pilot study.
After neoadjuvant chemotherapy, patients undergo sentinel lymph node (SLN) mapping
comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify
the SLN. Within 1-2 hours after injection, patients undergo SLN biopsy followed immediately
by definitive local surgery comprising modified radical mastectomy or breast segmentectomy
with axillary lymph node dissection. SLN and axillary lymph nodes are examined by
hematoxylin and eosin (H & E) staining for the presence or absence of metastases. If the
lymph nodes are negative for tumor by H & E, the lymph nodes are further analyzed by
immunohistochemistry. The primary tumor is analyzed by microarray analysis for gene
expression profile determinations.
Patients are followed at 2-3 weeks after surgery.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2-3 years.
Primary Purpose: Diagnostic
David N. Danforth, MD, MS
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|