CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
- Conditions
- Breast Cancer
- Registration Number
- NCT00635245
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
- Secondary Outcome Measures
Name Time Method Safety, tolerability and human anti-human antibodies (HAHA) response Measure of tumor glucose levels Pathological response Tumor size by MRI Tissue markers