Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Diagnostic	Active	18 to 64	Other	RMNHS-2282 EU-20351, NCT00082979

Objectives

Primary

1. 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.
2. Determine the prevalence of occult breast cancer in patients with cellular atypia undergoing duct endoscopy.

Secondary

1. Determine patient acceptance of duct endoscopy.
2. 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.
3. Determine potential molecular markers of malignancy by gene methylation, gene expression, and proteomics in these patients.

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

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

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

Expected Enrollment

A total of 45-60 patients will be accrued for this study within 2 years.

Outcomes

Comparison of cell yields and morphology from ductal lavage vs the ductal anatomy visualized at duct endoscopy
Prevalence of occult pathology (malignant and benign) as assessed by duct endoscopy on intraduct sampling
Sensitivity and specificity of ductal lavage to duct endoscopy in detecting atypia or malignancy
Comparison of cell yields vs final surgical pathology

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.

Trial Contact Information

Trial Lead Organizations

Royal Marsden - London

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Study coordinator		Ph: 44-20-7808-2783 Email: gerald.gui@rmh.nhs.uk

United Kingdom
England
	London
	Royal Marsden - London
		Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)	Ph:  44-20-7808-2783
			Email: gerald.gui@rmh.nhs.uk

Registry Information
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
Trial Start Date		2003-10-01
Registered in ClinicalTrials.gov		NCT00082979
Date Submitted to PDQ		2004-03-12
Information Last Verified		2005-12-05

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