Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior

OBJECTIVES:

- Collect , catalogue, and store biological specimens from patients with locally advanced
or metastatic breast cancer

- To collect clinical data from these patients containing identifiers, demographics,
epidemiologic review, clinical evaluation, treatment, and long-term follow-up.

- To provide an efficient bi-directional flow of clinical information and specimens
between laboratory and clinical scientists in order to foster innovative translational
research.

OUTLINE: This is a multicenter study.

Patients undergo core biopsy and blood sampling at diagnosis, between chemotherapy regimens,
and prior to definitive surgery. Tumor markers are assessed using immunohistochemistry and
flow cytometry.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Inclusion Criteria:

High suspicion of or known breast cancer (early or metastatic)

Lesion accessible for safe biopsy (as deemed by the treating physician).

Age ≥ 18 years.

ECOG performance status 0 - 2.

Ability to understand and willingness to sign an informed consent document.

If receiving therapeutic anticoagulation; it should be discontinued temporarily prior to
biopsy for a length of time to be determined by the study doctor.

Adequate marrow function, defined as absolute neutrophil count ≥ 1.5 x 109/L and platelets
≥ 100 x 109/L required only for biopsies of vital organs (lung, liver, etc.)

Exclusion Criteria:

Concurrent disease or condition that would make the patient inappropriate for study
participation or any serious medical or psychiatric disorder that would interfere with the
subject's safety.

Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.

History of serious or life-threatening allergic reaction to local anesthetics (i.e.
lidocaine, xylocaine)

Pregnant women are excluded because there may be an increased risk to both mother and fetus
in the setting of conscious sedation, which is required for biopsies of certain anatomic
sites (e.g. liver, lung). Also, ionizing radiation from CT-guided biopsies may pose a risk
to the unborn fetus.

Cardiac disease making it unsafe to biopsy in the opinion of the treating physician.

If patients receiving bevacizumab or other angiogenesis inhibitors are less than 6 weeks
from last dose of the angiogenesis inhibitor, they should not undergo research core
biopsies of vital organs (lung, liver, etc.) on this protocol because of the concern for
the possibility of increased bleeding risk and delayed healing. Patients receiving
bevacizumab or other angiogenesis inhibitors who are undergoing a research biopsy of the
breast, peripheral lymph node or a skin punch biopsy must be two weeks from the last dose
of the angiogenesis inhibitor.