A Phase III Trial For Patients With Metastatic Breast Cancer
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/
capecitabine doublets, with crossover to the alternate agent. The experimental arm will
receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75
mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive
docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1
through 14 repeated every three weeks. Patients who progress on the experimental arm, will be
treated with capecitabine as dosed on the comparator arm. Patients who progress on the
comparator arm will be treated with gemcitabine as dosed on the experimental arm.