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

Leo W. Jenkins Cancer Center

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Leo W. Jenkins Cancer Center

Greenville, North Carolina, United States

Outcomes

Primary Outcomes

To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy

Compare tumor derived exosomes at baseline, monthly during chemotherapy, at the completion of chemotherapy treatment, and after surgery to determine residual cancer burden. Tumor derived exosome expression will be correlated with both clinical and pathologic response.

Time frame: up to 2 years from start of study

Data from ClinicalTrials.gov

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