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

Breast Cancer Clinical Trial

Official title:

Breast Cancer Biomarkers Based on Fine Needle Aspirates

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00041353
• Other study ID #: FCCC-02010
• Secondary ID: CDR0000069491NCI
• Status: Withdrawn
• Phase: N/A
• First received: July 8, 2002
• Last updated: July 10, 2013
• Est. completion date: September 2002

Study information

• Verified date: July 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2002
• Est. primary completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• cytology specimen collection procedure

Procedure:
• comparison of screening methods

• study of high risk factors

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)