Collecting and Storing Tissue Samples From Women With or Without Breast Cancer

OBJECTIVES:

- To create a database that includes environmental, demographic, phenotypic, clinical,
pathologic, genetic, and prognostic factors in large cohorts of women with different
stages of breast cancer.

- To create a tissue repository that contains DNA, RNA, or protein from tumor tissue or
normal tissue, peripheral blood lymphocytes, and plasma that are linked to frozen and/or
paraffin-embedded pathology specimens.

OUTLINE: Patients undergo tumor tissue and normal tissue sample collection at the time of
medically indicated surgery or biopsy. Archival tissue may also be collected. Patients and
normal volunteers also undergo blood and urine sample collection. A repository of tissue,
blood, and urine samples will be established to facilitate current and future research
studies to learn about the biologic features of breast cancer development and progression.
Research studies may include molecular pathology studies and gene and protein expression
studies.

Patients' medical records are reviewed over approximately 5 years to determine if the test
results are associated with health status. Patients do not receive the results of individual
testing.

- Any subject > 18 years of age with a breast lesion which is suspected to be cancer or
a known breast cancer lesion (primary or metastatic) who agrees to donate tissue/body
fluids. Collection of samples can occur:

- At the time of breast biopsy or surgery for benign disease

- At the time of breast biopsy or surgery for suspected breast cancer

- At the time of biopsy or surgery for histologically proven breast cancer at any stage
of disease.

- From archival materials

- In a normal volunteer who wishes to donate blood and/or urine to allow for a control
population against whom the cancer patient can be compared

- Subjects have to sign informed consent for study of tumor specimens as part of a
research project.

- Patients have to give permission for their tumor specimens to be obtained from outside
institutions for molecular analyses.

- All subjects participating in this protocol have to be willing to be followed for
recurrence, relapse and death from disease.