Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

Summary: RATIONALE: Diagnostic procedures, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect and assess breast cancer cells early and plan more effective treatment.
  PURPOSE: This phase II trial is studying how well nipple aspiration, ductal lavage, and duct endoscopy work in assessing cancer cells in women who are undergoing surgery for breast cancer.

Detailed description: 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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer
  -  No metastatic disease
  -  No inflammatory breast cancer
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Female
  Menopausal status
  -  Not specified
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  No active infection or inflammation in the breast under study
  -  No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
  -  No severe illness
  -  Not unconscious
  -  No mental illness or handicap
  -  No nursing within the past 12 months
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  No prior breast implantation on side of proposed lavage
  -  No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or other surgery that may disrupt the ductal systems within 2 cm of the nipple
  -  Biopsies and fine-needle aspirations > 2 cm from the nipple are allowed

Relevance to patient case: not relevant