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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01344109
• Other study ID #: ECU 003
• Status: Withdrawn
• Phase: N/A
• First received: April 27, 2011
• Last updated: July 18, 2017
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2017
• Source: Leo W. Jenkins Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
United States	Leo W. Jenkins Cancer Center	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Leo W. Jenkins Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 years from start of study