Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
Recruitment status was: Recruiting
RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment.
PURPOSE: This phase II trial is studying how well breast duct endoscopy works in assessing cellular atypia (abnormal cells) in the breast ducts of women with a genetic risk for breast cancer.
Genetic: cytogenetic analysis
Genetic: proteomic profiling
Other: cytology specimen collection procedure
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: breast duct lavage
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Evaluation of the Role of Duct Endoscopy in the Assessment of Cellular Atypia Within Breast Duct Fluid in High-Risk Women Carrying BRCA1/2 or p53 Gene Mutations|
- Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy [ Designated as safety issue: No ]
- Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling [ Designated as safety issue: No ]
- Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy [ Designated as safety issue: No ]
- Comparison of cell yields vs final surgical pathology [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
- Correlate cell yield and morphology findings from ductal lavage with duct endoscopy findings and any subsequent surgical pathology findings in high-risk women with BRCA1, BRCA2, or p53 gene mutations who have cellular atypia.
- Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy.
- Determine patient acceptance of duct endoscopy.
- 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.
OUTLINE: Patients undergo nipple aspiration to identify productive ducts and collect fluid for tumor marker assessment followed by ductal lavage over 15 minutes. Patients undergo duct endoscopy over approximately 30 minutes under local anesthesia. If no abnormality is found, duct endoscopy is repeated in 6 months. If the repeat duct endoscopy is normal, patients continue to undergo nipple aspiration or ductal lavage as specified in protocols RMNHS-2242 and RMNHS-2269. If an abnormality is found during either the initial or repeat duct endoscopy, patients may undergo further assessment comprising imaging or biopsy and/or appropriate surgical intervention.
Fluid is analyzed for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation studies, gene expression arrays, and proteomic analysis.
Patients are followed for at least 5 years.
PROJECTED ACCRUAL: A total of 45-60 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082979
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|OverallOfficial:||Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)||Royal Marsden NHS Foundation Trust|