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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | combination of CP-751,871 + docetaxel administered |
|
| Arm B | Active Comparator | chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-751,871 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) | 3 years | |
| Overall Response | 3 years | |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C525021 | figitumumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted. |
|
| 3 years |
| Safety and tolerability | 3 years |
| Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire | 3 years |
| Pharmacokinetics of CP-751,871 | 3 years |
| Optional tissue markers of the IGF-1R pathway from tumor tissue obtained | 3 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |