A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Letrozole Versus Letrozole Alone As First Line Therapy In Post-Menopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of
Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of
patients had treatment related liver events with the majority of severe events resulting in
permanent study treatment discontinuation.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS) Based on Independent Radiologist
Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PFS assessed by independent radiologist was to be reported.
Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
Pfizer CT.gov Call Center
United States: Food and Drug Administration
|Pfizer Investigational Site||Blendora, California 91740|
|Pfizer Investigational Site||Detroit, Michigan 48201|
|Pfizer Investigational Site||Springfield, Illinois 62701-1014|
|Pfizer Investigational Site||North Adams, Massachusetts 01247|