A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Withdrawn before enrolling
Conditions studied: Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01344109
- Run by
- Leo W. Jenkins Cancer Center
- People needed
- 0
- Starts
- 2011-02-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-07-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Leo W. Jenkins Cancer Center — Greenville, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.