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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breast Cancer Biomarkers Based on Fine Needle Aspirates

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: cytology specimen collection procedure
* Procedure: comparison of screening methods
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cytology specimen collection procedure|nan|
|Procedure: comparison of screening methods|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ, lobular breast carcinoma in situ