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

Breast Cancer Clinical Trial

Official title:

The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081003
• Other study ID #: CDR0000358797
• Secondary ID: RMNHS-2278EU-203
• Status: Completed
• Phase: N/A
• First received: April 7, 2004
• Last updated: July 22, 2014
• Start date: November 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: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.

PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.

Description:

OBJECTIVES:

Primary

• 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

• Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.

• Determine cancer risk and incidence utilizing these methods of screening in these participants.

• Observe the natural history of atypia in these participants over a total of 10 years.

• Determine whether these techniques may serve as supplementary tools in future screening of these participants.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

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

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• gene expression analysis

• protein expression analysis

Other:
• cytology specimen collection procedure

• laboratory biomarker analysis

• physiologic testing

Procedure:
• breast duct lavage

• endoscopic biopsy

• study of high risk factors

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,