A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Inclusion Criteria:

- Women with biopsy proven invasive carcinoma of the breast

- Women with locally advanced breast cancer and breast tumors measuring >/= 2cm who are
deemed candidates for preoperative chemotherapy

- Age >/= 18 years old

- Expected survival >/= 6 months

- Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at initiation of
study

- Initial required laboratory values:

Absolute neutrophil count >/= 1.5 x 10(9)/L Platelet count >/= 100,000 x 10(9)/L
Creatinine clearance >/= 50mL/min (calculated by Cockcroft-Gault method) Liver function
tests (AST, ALT, total bilirubin) childbearing potential)

- Women may be enrolled on ongoing therapeutic preoperative chemotherapy trials

Exclusion Criteria:

- No prior chemotherapy for breast cancer

- No limitations for prior radiation therapy

- No active, serious infection or medical or psychiatric illness likely to interfere
with participation in this trial

- Non-pregnant and non-nursing patients only. Patients of reproductive potential must
agree to use an effective means of birth control

- No prior liver transplant or bone marrow transplant