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)

NCT00266799 ↗

Phase 3 Completed 210 enrolled Merck Sharp & Dohme LLC Essex Pharma GmbH · collab
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

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1250 mg/m2 Oral
Subject Pegylated liposomal doxorubicin Unknown 50 mg/m2 Intravenous

Indications