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

NCT01344109 | Withdrawn

• 1 other identifier: ECU 003
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Breast cancer patients

Newly diagnosed patients with breast cancer presenting with operable breast tumor prior to initiation of of neoadjuvant chemotherapy (choice of chemotherapy will be the the treating physician's discretion)

Healthy volunteers

Adult women without a cancer diagnosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed breast cancer patients prior to neoadjuvant chemotherapy treatment and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead

Study Sites (1)

Leo W. Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum will be centrifuged to plasma which will be transferred to alliquots, and frozen prior to shipping. Exosomes will be extracted from the frozen plasma with half of the sample used for antibody testing and the remaining sample will be used for RNA analysis.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rachel Raab, MD

  Brody School of Medicine at ECU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trials Manager

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)