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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00082979
• Other study ID #: CDR0000361751
• Secondary ID: RMNHS-2282EU-203
• Status: Recruiting
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: August 23, 2013
• Start date: October 2003

Study information

• Verified date: December 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• cytogenetic analysis

• proteomic profiling

Other:
• cytology specimen collection procedure

• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• breast duct lavage

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - London	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy			No
Primary	Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling			No
Primary	Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy			No
Primary	Comparison of cell yields vs final surgical pathology			No