Breast Cancer Clinical Trial
Official title:
Breast Cancer Biomarkers Based on Fine Needle Aspirates
RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for
breast cancer may improve the ability to detect breast cancer cells early and plan effective
treatment.
PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration
specimens from women at increased or normal risk of breast cancer.
OBJECTIVES:
- Compare specific biomarkers, including cellular morphology (cytology), proliferation
index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle
aspirate specimens from women at increased vs normal risk of breast cancer.
- Determine whether these specimens are adequate to perform the biomarker assays and
whether this technique could be used in the general outpatient setting.
- Determine whether biomarker levels in these patients are concordant or discordant with
individual clinical risk of breast cancer.
- Determine whether 1 or more biomarkers can distinguish high-risk from control patients.
- Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis
from the breast biopsy.
OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to
the beginning of elective surgery. Specimens are analyzed for the presence of specific
biomarkers.
PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.
;
Primary Purpose: Screening
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