Breast Cancer Biomarkers Based on Fine Needle Aspirates
30 Years
N/A
Female
Breast Cancer
Trial Information
Breast Cancer Biomarkers Based on Fine Needle Aspirates
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.
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:
Age:
- 30 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- 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
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Screening
Principal Investigator
Michael H. Torosian, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000069491
NCT ID:
NCT00041353
Start Date:
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- lobular breast carcinoma in situ
- Breast Neoplasms
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