Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer

Fox Chase Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

SCREENING

Conditions

Breast Cancer

Interventions

cytology specimen collection procedureOTHER

comparison of screening methodsPROCEDURE

study of high risk factorsPROCEDURE

Eligibility

Sex: FEMALEMin age: 30 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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