Surrogate Endpoints in Prevention Studies and Ductal Lavage
- Evaluate cell morphology and protein expression of breast epithelial cells in ductal
lavage samples as a marker of tamoxifen effect from women with breast cancer or from
women at high risk for developing breast cancer.
- Evaluate methylation status of genes previously identified to be related to neoplastic
progression of cells in ductal lavage samples from these participants.
- Evaluate the protein profile of nipple aspiration fluid from these participants before
and after treatment with tamoxifen.
OUTLINE: This is a multicenter study.
Participants who are eligible for tamoxifen chemoprevention therapy undergo ductal lavage.
Participants are informed of cytological findings and choose to receive oral tamoxifen once
daily for 5 years vs observation only. All participants undergo repeat ductal lavage at 6
months. Participants with atypical cytology undergo a third ductal lavage at 12 months.
Mammographic density is measured at study entry and at 12 months.
Ductal cells are analyzed for methylation status of candidate genes.
Participants are followed as clinically indicated.
PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.
Observational Model: Cohort, Time Perspective: Prospective
Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect
Before and after tamoxifen treatment
Seema A. Khan, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Comprehensive Cancer Center at University of Alabama at Birmingham||Birmingham, Alabama 35294|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|