Statement of Work SPECIFIC: Design, approval and activation of CCR5 targeted therapy trial in patients with HER-2 negative metastatic breast cancer. Year 1. Completion of study design followed by regulatory review and approval and final activation with initial screening of potential candidates we will also optimize CTCs screening and CCR5 staining as correlative study in the clinical trial. In the statistical design we will include stopping rules for safety and efficacy to maximize the opportunity of early detection of antimetastatic properties. At least three months for IRB approval from submission of this proposal. We hope to enroll first few patients for the Phase 1b portion of the study; Year 2. Accrual of patients with MBC in the Phase 1b/Phase 2 of the study with initial safety end preliminary data. The latter will demonstrate at initial review (early stopping rules) the benefit of the combination regimen. With regards to the correlative studies: Two or more blood samples will be collected. Each tube will first be centrifuged to separate and collect the plasma. The cells will be resuspended and filtered. One sample will be stained and used for the cells and markers of interest. The microscope slide containing the captured cells will be evaluated using to filtration systems ( Creatv and ScreenCell) before CCR5 staining of CTCs and CAMLs. Enumeration will be performed using CellSearch. The plasma will be stored at -80°C for future research.
|Effective start/end date||2/29/16 → 12/31/16|
- Thomas Jefferson University (SUB NO: 080-03800-N20602)
- Dr. Ralph and Marian Falk Medical Research Trust (SUB NO: 080-03800-N20602)
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