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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms

Thank you

Trial Information

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


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) 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

up to 2 years from start of study

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

ECU 003

NCT ID:

NCT01344109

Start Date:

February 2011

Completion Date:

December 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Leo W. Jenkins Cancer CenterGreenville, North Carolina