A Multicenter Breast Cancer Biospecimen Registry

Inclusion Criteria:

1. Females of all racial and ethnic groups who are 40 years or older.

2. Women must:

1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of
any breast screening or diagnostic imaging, such as mammogram, and

2. be selected or scheduled for a breast biopsy which has not yet been conducted at
the time of enrollment.

Exclusion Criteria:

1. Inability to sign informed consent.

2. More than one radiological finding.

3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a
suspected breast malignancy targeted for biopsy).

4. Any known or suspected acute illness or condition - including acute infections - at
the time of enrollment or within the previous 30 days.

5. Any surgery, hospitalization, or institutionalization (such as in a nursing home)
during the previous 3 months.

6. Received any experimental therapeutic treatment during the previous 3 months.

7. Received any blood product transfusion within the previous 3 months.

8. Use of illegal drugs during the previous 3 months.

9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.