Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Summary
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
Timeline
- Start
- 2007-02
- Primary completion
- 2012-09
- Completion
- 2014-06
Outcome
Missed primary endpoint
Stopped (Enrollment): “This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns.”
registry analysis (superiority or other test); CP-751,871 + Exemestane vs Exemestane; p = 0.560; Hazard Ratio (HR) 0.912 (80% CI 0.744 to 1.118); Log Rank NCT00372996 ↗
registry analysis (superiority or other test); CP-751,871 + Exemestane vs Exemestane; p = 0.331; Hazard Ratio (HR) 0.764 (70% CI 0.572 to 1.020); Log Rank; note: 2-sided p-value from unstratified log-rank test NCT00372996 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Exemestane | Small molecule | 25 mg | Oral |
| Subject | Figitumumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Fulvestrant | Small molecule | — | — |