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.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer	Procedure: biological markers  Procedure: breast duct lavage  Procedure: cytogenetic analysis  Procedure: cytologic sampling  Procedure: diagnostic test	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

United Kingdom, England
      Royal Marsden NHS FoundationTrust - London, London,  England,  SW3 6JJ,  United Kingdom; Recruiting

Study chairs or principal investigators

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng),  Study Chair,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000361760; RMNHS-2283; EU-20353; NCT00083018
Record last reviewed:  April 2004
Last Updated:  April 5, 2005
Record first received:  May 14, 2004
ClinicalTrials.gov Identifier:  NCT00083018
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08