A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/-0001 |
| Start Date: | February 2011 |
| End Date: | December 2014 |
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) 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
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