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

Alternate Title

Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Diagnostic Active 18 and over Other RMNHS-2283 EU-20353, NCT00083018

Objectives

Primary

1. Correlate the cell yield and morphology findings from ductal lavage with duct endoscopy findings and surgical pathology findings in women with breast cancer.
2. Determine the sensitivity and specificity of nipple aspiration, ductal lavage, and duct endoscopy in detecting established breast cancer in these patients.

Secondary

1. Compare the intraduct environment of cancer-involved ducts in the affected breast vs the ductal systems in the contralateral breast of these patients.
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.
4. Compare the biochemistry and protein analysis of the intraductal fluid vs serum analysis in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of breast cancer



• No metastatic disease



• No inflammatory breast cancer



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• No prior breast implantation on side of proposed lavage
• No prior subareolar (e.g., papilloma resections, biopsies, or fine needle aspirations) or 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

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No active infection or inflammation in the breast under study
• No known allergy to eutectic mixture of local anesthetics (EMLA®) cream or lidocaine
• No severe illness
• Not unconscious
• No mental illness or handicap
• No nursing within the past 12 months
• Not pregnant

Expected Enrollment

A total of 100 patients will be accrued for this study within 1 year.

Outcomes

Correlation of cell yields and morphology in ductal lavage with duct endoscopy appearances and findings
Sensitivity and specificity of ductal lavage with or without ductoscopy in detecting atypical cells
Comparison of cell yields vs final surgical pathology of the operative specimens

Outline

Patients undergo nipple aspiration, ductal lavage, and duct endoscopy under general anesthesia immediately before breast surgery. Fluid and tissue obtained are examined for tumor markers by immunohistochemistry. Candidate genes are analyzed by gene methylation, gene expression arrays, and proteomic profiling.

Patients are followed at 24 hours and at 1 week.

Trial Contact Information

Trial Lead Organizations

Royal Marsden - London

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Protocol chair		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 Nipple Aspiration, Ductal Lavage And Duct Endoscopy At The Time Of Surgery In Patients With Breast Cancer
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00083018
Date Submitted to PDQ		2004-03-12
Information Last Verified		2005-12-05

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