Epirubicin and Paclitaxel, Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Anthracycline-taxane regimens are effective means of postponing progression in metastatic
breast cancer. It is yet unclear whether addition of capecitabine to this combination
improves the treatment outcome.
Patients with advanced breast cancer are randomized to first-line chemotherapy with a
combination of epirubicin (Farmorubicin®) and paclitaxel (Taxol®) alone (ET) or in
combination with capecitabine (Xeloda®, TEX). Starting doses for ET are epirubicin 75 mg/m2
plus paclitaxel 175 mg/m2, and for TEX epirubicin 75mg/m2, paclitaxel 155 mg/m2, and
capecitabine 825 mg/m2 BID for 14 days. Subsequently, doses are tailored related to side
effects.
Primary endpoint is progression-free survival (PFS); secondary endpoints are overall survival
(OS), time to treatment failure (TTF), objective response (OR), safety and quality of life
(QoL).