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

Alternate Title

Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Natural history/Epidemiology, Screening Active 18 to 64 Other RMNHS-2278 EU-20352, NCT00081003

Objectives

Primary

1. Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.

Secondary

1. Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
2. Determine cancer risk and incidence utilizing these methods of screening in these participants.
3. Observe the natural history of atypia in these participants over a total of 10 years.
4. Determine whether these techniques may serve as supplementary tools in future screening of these participants.

Entry Criteria

Disease Characteristics:

• Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer



• No concurrent 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 subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple
• No prior breast implantation on proposed lavage side

Patient Characteristics:

Age

• 18 to 64

Sex

• Female

Menopausal Status

• Premenopausal or postmenopausal

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No prior allergy to EMLA cream or lidocaine
• No severe illness that would preclude study participation
• No mental illness or handicap that would preclude study compliance
• No concurrent active infection or inflammation in the breast being studied
• Not unconscious
• Not pregnant
• No nursing within the past 12 months

Expected Enrollment

A total of 1,000 participants will be accrued for this study within approximately 4 years.

Outline

Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.

Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.

Participants are followed annually for a total of 10 years.

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		The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
Trial Start Date		2003-11-01
Registered in ClinicalTrials.gov		NCT00081003
Date Submitted to PDQ		2004-02-23
Information Last Verified		2005-12-05