Standard Versus Continuous Capecitabine in Advanced Breast Cancer
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Capecitabine is active in metastatic breast cancer but the conventional schedule (1250
mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in
up to 50% of patients leading to those reductions. There are theoretical reasons to
administer S-phase specific agents in continuous, protracted rather than intermittent
schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks
on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter
administer approximately the same cumulative dose of capecitabine as the standard schedule.
The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from
50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor
activity in both arms.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Hospital San Carlos, Madrid
Collaborators:
Complexo Hospitalario Universitario de A Coruña Hospital Juan Canalejo, La Coruña, Spain