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Brief Title: CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
Official Title: A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
Study ID: NCT00635245
Brief Summary: RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.
Detailed Description: Primary * To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment. Secondary * To assess changes in tumor glucose levels after CP-751871 treatment using magnetic resonance spectroscopy in these patients. * To assess the safety, tolerability, and immunogenicity of CP-751871 in these patients. * To assess the effect of CP-751871 on Insulin-like Growth Factor 1 receptor (IGF-1R) signaling markers in tumor tissues in these patients. * To assess the clinical efficacy of CP-751871 in these patients (MRI and pathological responses). OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway. After completion of study treatment, patients will be followed for 5 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Name: Douglas Yee, MD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: PRINCIPAL_INVESTIGATOR