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

This study is currently recruiting participants.
Verified January 2012 by Leo W. Jenkins Cancer Center
Sponsor:
Information provided by (Responsible Party):
Jackie Unger, Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT01344109
First received: April 27, 2011
Last updated: January 3, 2013
Last verified: January 2012
History of Changes
  Purpose

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.


Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Leo W. Jenkins Cancer Center:

Primary Outcome Measures:
  • To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy [ Time Frame: up to 2 years from start of study ] [ Designated as safety issue: No ]
    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.


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.


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344109

Locations
United States, North Carolina
Leo W. Jenkins Cancer Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Jackie Unger, RN, OCN, CCRC     252 744-9016     Ungerj@ecu.edu    
Principal Investigator: Rachel E. Raab, MD            
Sub-Investigator: Adam Asch, MD            
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
  More Information

No publications provided

Responsible Party: Jackie Unger, Clinical Trials Manager, Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier: NCT01344109     History of Changes
Other Study ID Numbers: ECU 003
Study First Received: April 27, 2011
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013