Trial Information

Evaluation Of The Role Of Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer

OBJECTIVES:

Primary

- Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy
findings and surgical pathology findings in women with breast cancer.

- Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct
endoscopy in detecting established breast cancer in these patients.

Secondary

- Compare the intraduct environment of cancer-involved ducts in the affected breast vs
the ductal systems in the contralateral breast of these patients.

- Perform immunohistochemical analysis (including estrogen receptor, progesterone
receptor, HER2-neu receptor, epidermal growth factor receptor, p53, and proliferation
marker expression) for markers potentially associated with breast cancer in these
patients.

- Determine potential molecular markers of malignancy by gene methylation, gene
expression, and proteomics in these patients.

- Compare the biochemistry and protein analysis of the intraductal fluid vs serum
analysis in these patients.

OUTLINE: Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general
anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for
tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation,
gene expression arrays, and proteomic profiling.

Patients are followed at 24 hours and at 1 week.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.