This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.
Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.
Progression Free Survival
Time frame: 3 years
Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)
Time frame: 3 years
Overall Response
Time frame: 3 years
Overall Survival
Time frame: 3 years
Safety and tolerability
Time frame: 3 years
Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire
Time frame: 3 years
Pharmacokinetics of CP-751,871
Time frame: 3 years
Optional tissue markers of the IGF-1R pathway from tumor tissue obtained
Time frame: 3 years
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