Duct Endoscopy in Assessing Cellular Atypia in the Breast Duct Fluid of Women With a Genetic Risk for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00082979
First received: May 14, 2004
Last updated: August 23, 2013
Last verified: December 2005
  Purpose

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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2003
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, 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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082979

Locations
United Kingdom
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)    44-20-7808-2783    gerald.gui@rmh.nhs.uk   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Investigator: Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng) Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00082979     History of Changes
Other Study ID Numbers: CDR0000361751, RMNHS-2282, EU-20351
Study First Received: May 14, 2004
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014