Breast Cancer Biomarkers Based on Fine Needle Aspirates


N/A
30 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Breast Cancer Biomarkers Based on Fine Needle Aspirates


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Michael H. Torosian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069491

NCT ID:

NCT00041353

Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • lobular breast carcinoma in situ
  • Breast Neoplasms

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