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Home > "D" Clinical Trials Conditions > Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer  Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Royal Marsden NHS Trust ,
Synopsis: RATIONALE: Diagnostic procedures, such as breast duct endoscopy, may improve the ability to detect breast cancer earlier and plan more effective treatment. PURPOSE: Phase II diagnostic trial to study the effectiveness of breast duct endoscopy in assessing cellular atypica (abnormalcells) in the breast ducts of women who have a genetic risk for breast cancer.
Details: OBJECTIVES: Primary - 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. Secondary - 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of cellular atypia in nipple aspirate or ductal lavage fluid - Enrollment on RMNHS-2242 or RMNHS-2269 required - No inflammatory breast cancer - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 to 64 Sex - Female Menopausal Status - Any status Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No prior allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine - No severe illness that would preclude study participation - No mental illness or handicap that would preclude study compliance - No active infection or inflammation in the breast being studied - No nursing within the past 12 months - Not pregnant - Not unconscious PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No prior tamoxifen Radiotherapy - Not specified Surgery - No prior subareolar surgery (e.g., papilloma resections, biopsies, or fine needle aspirations) or any 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 - No prior breast implantation on proposed lavage side Other - No prior chemopreventative agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeraldGui, , Royal Marsden NHS Trust
Royal Marsden NHS Trust - London *Recruiting*
London, England, SW3 6JJ
United Kingdom
Recruiting Gerald Gui 44-20-7808-2783
Additional Information:
Study ID Numbers: CDR0000361751; EU-20351,RMNHS-2282
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082979
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Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
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