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

Withdrawn

• Conditions: Breast Neoplasms

• Registration Number: NCT01344109
• Lead Sponsor: Leo W. Jenkins Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy	up to 2 years from start of study	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.

Trial Locations

Locations (1)

Leo W. Jenkins Cancer Center; 🇺🇸 Greenville, North Carolina, United States