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

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

This is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.

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) </= 2.5 x ULN Urine or serum HCG negative (if female of 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