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.

Condition	Treatment or Intervention
Cancer of the Breast Diagnostic Techniques and Procedures	Procedure: screening  Procedure: screening intervention  Drug: study of high risk factors  Drug: comparison of screening methods  Drug: cytologic sampling

Further Study Details: 

OBJECTIVES: I. 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. II. Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting. III. Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer. IV. Determine whether 1 or more biomarkers can distinguish high-risk from control patients. V. Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy.

PROTOCOL 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.

Ages Eligible for Study:  30 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics
• Surgery: See Disease Characteristics

--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

Study chairs or principal investigators

Michael H. Torosian,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000069491; FCCC-02010; NCI-G02-2095
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041353
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08