This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The goal of this study is to evaluate the clinical potential of CP-751,871 as a neoadjuvant treatment in patients with early breast cancer. This fully human monoclonal antibody specifically binds IGF-1R to inhibit cell growth. Response to this agent will be monitored in vivo using MRS and MRI, particularly by measuring choline as an early pharmacodynamic marker of anti-tumor activity. These measurements will be performed on the 4 T system and spectra processed and quantified using methods developed at the CMRR. Early breast cancer patients will receive 20mg/kg of CP-751,871 on Days 1 and 22 of the study. Optional additional doses can be administered at three-week intervals at the discretion of the investigator based on tumor response. Safety and tolerability will be monitored throughout the study. MRS will be performed on the patients prior to treatment and on Days 8 and 29 (+/- 3 days). MRI will be performed at the time of MRS to determine changes in tumor size and for proper spectroscopy voxel placement. MRS will be used for monitoring changes in tCho and also to measure tumor glucose levels. Surgery will be scheduled within 21 days of the final CP-751,871 dose. In addition to MR monitoring, tumor tissue from primary diagnostic biopsies and from the surgical treatment procedure will be analyzed for genes and proteins related to the IGF-R1 pathway to observe the effects of CP-751,871 on the IGF signaling pathways.
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