Breast Cancer Clinical Trial
A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
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.
Eligibility 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)
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Greenville North Carolina, 27834, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.