Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
NCT ID: NCT00082979
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2003-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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cytogenetic analysis
proteomic profiling
cytology specimen collection procedure
immunohistochemistry staining method
laboratory biomarker analysis
breast duct lavage
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
64 Years
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Role:
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden - London
London, England, United Kingdom
Countries
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Facility Contacts
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Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)
Role: primary
Other Identifiers
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RMNHS-2282
Identifier Type: -
Identifier Source: secondary_id
EU-20351
Identifier Type: -
Identifier Source: secondary_id
CDR0000361751
Identifier Type: -
Identifier Source: org_study_id