Core Biopsies for Establishing a Breast Tumor Tissue Repository

PRIMARY OBJECTIVES:

I. To develop a baseline and serial breast cancer core biopsy repository within the
University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer
Program.

II. To develop and maintain a secure clinical database of relevant demographic, clinical,
pathologic and longitudinal outcome characteristics of the samples to be banked.

III. To have an efficient process for the distribution of de-identified samples from the bank
to researchers with institutional review board (IRB)-approved protocols or exemptions for the
study of breast cancer-related questions. These studies would include analyses of tumor
proteins and nucleic acids, serum/plasma and germline deoxyribonucleic acid (DNA) and immune
cells in relationship to other baseline and follow-up clinical and pathological variables.

OUTLINE: Patients are assigned to 1 of 4 cohorts.

COHORT I (PATIENTS WITH NEWLY DIAGNOSED EARLY STAGE BREAST CANCER WHO WILL UNDERGO DEFINITIVE
SURGERY BEFORE ANY SYSTEMIC THERAPY): Patients undergo baseline and, if applicable, follow-up
core needle biopsies of breast cancer in the breast, regional nodes, and distant metastases.
Patients who experience a recurrence or progression after therapy undergo additional core
biopsies at the time of recurrence. Clinical and blood specimens will also be gathered.

COHORT II (PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER WHO WILL RECEIVE STANDARD OF CARE
SYSTEMIC THERAPY BEFORE SURGERY OR PATIENTS WITH ADVANCED UNRESECTABLE DISEASE): Patients
undergo core biopsy, clinical, and blood sample collection as in Cohort I. Patients also
undergo biopsies at a specific time point following the initiation of standard systemic
therapy.

COHORT III (PATIENTS BEING EVALUATED FOR A SUSPICIOUS BREAST MASS THAT HAS A HIGH LIKELIHOOD
OF BEING CANCER): Patients undergo core biopsy, clinical, and blood sample collection as in
Cohort I. Patients who have Breast Imaging-Reporting and Data System (BIRADS) 4b, 4c, and 5
lesions may undergo up to 6 additional 6 core biopsies.

COHORT IV (PATIENTS WITH BREAST CANCER RECURRENCE OR PROGRESSION [LOCAL, REGIONAL, OR
DISTANT/METASTATIC]): Patients undergo core biopsy, clinical, and blood sample collection as
in Cohort I. Patients may also undergo 1-3 extra core biopsies.

After completion of study, patients are followed up every 6 months.

Inclusion Criteria:

- Known or suspected breast cancer

Exclusion Criteria:

- Inability to sign informed consent

- Known bleeding disorder

- Use of anticoagulant medications (heparin, warfarin, etc.) within one week prior to
biopsy

- Use of antiplatelet medications (aspirin, clopidogrel, etc.) within one week prior to
biopsy