Status:
UNKNOWN
Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-64 years
Phase:
PHASE2
Brief Summary
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 ho...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00082979
Start Date
October 1 2003
Last Update
August 26 2013
Active Locations (1)
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1
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ