A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer in Women 60 Years and Older
This is an open-label (all people know the identity of the intervention), randomized (the
study medication is assigned by chance), multicenter study comparing with pegylated
liposomal doxorubicin (PLD) with capecitabine as first line chemotherapy of metastatic
breast cancer in women 60 years and older. The study consists of a screening Phase (up to 14
days prior to treatment), treatment phase (up to 1 year), and post-treatment follow-up
phase. The planned duration of treatment was 1 year in the absence of disease progression or
unacceptable toxicity. Approximately 300 patients will be enrolled and randomly assigned to
receive 1 of 2 treatment groups (PLD or capecitabine). Safety evaluations will consist of
vital sign examination, physical examination, incidence and severity of adverse events, and
laboratory tests findings and will be followed throughout the study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression
Time to disease progression is the duration in months from the date of randomization to the first documented evidence of disease progression or death caused by disease progression before the end of study. Time to disease progression will be compared between patients treated with doxorubicin and capecitabine.
Up to disease progression or death
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration