A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
Douglas Yee, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration