drugset / Trial / NCT00657137
APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-09
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | apricoxib | Small molecule | 400 mg | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Lapatinib | Small molecule | — | — |