At a glance
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A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (PELICAN Trial)
In Brief
A Phase 3 clinical trial evaluating Pegylated liposomal doxorubicin (SCH 200746) and Capecitabine for Breast Cancer. Completed, enrolled 210 participants.
Detailed 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.
Study Details
Timeline
Interventions
pegylated liposomal doxorubicin (50 mg/m\^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity
capecitabine (1250 mg/m\^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity