drugset / Trial / NCT00266799
The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. The primary objective of the study is to compare the time to disease progression, although overall response rates, overall survival, quality of life, time to treatment failure, and safety and tolerability will also be assessed.
Timeline
- Start
- 2006-01-13
- Primary completion
- 2010-09-29
- Completion
- 2010-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Pegylated liposomal doxorubicin | Unknown | 50 mg/m2 | Intravenous |