Breast Cancer Clinical Trial
Official title:
The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
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.
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.
;
Primary Purpose: Screening
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