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

Temple University Health System (TUHS)

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Other: cytology specimen collection procedure; Procedure: study of high risk factors; Procedure: comparison of screening methods

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00041353

FCCC-02010

NCI-G02-2095

CDR0000069491 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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