NCT00041353WithdrawnNot Applicable
Breast Cancer Biomarkers Based on Fine Needle Aspirates
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Fox Chase Cancer Center
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Screening
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer OR a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast OR
- •No increased risk of breast cancer as determined by a lack of the above conditions
- •Scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump
- •No prior bilateral mastectomy or bilateral breast irradiation
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •30 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No active invasive malignancy in any site except basal cell or squamous cell skin cancer
- •No significant medical or psychiatric problems that would preclude study
- •No evidence of excessive use of narcotics or drug dependency
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •See Disease Characteristics
Exclusion Criteria
- Not provided
Investigators
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