CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
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.
Other: imaging biomarker analysis
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: conventional surgery
Procedure: magnetic resonance spectroscopic imaging
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer|
- Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy [ Designated as safety issue: No ]
- Safety, tolerability and human anti-human antibodies (HAHA) response [ Designated as safety issue: Yes ]
- Tissue markers [ Designated as safety issue: No ]
- Measure of tumor glucose levels [ Designated as safety issue: No ]
- Pathological response [ Designated as safety issue: No ]
- Tumor size by MRI [ Designated as safety issue: No ]
- To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635245
|Principal Investigator:||Douglas Yee, MD||Masonic Cancer Center, University of Minnesota|