NCT01433614

Epirubicin and Paclitaxel, Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer

Treatment With the Combination of Epirubicin and Paclitaxel Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer. A Multicenter, Randomized Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Thomas Hatschek · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Epirubicin	75 mg/m2 i.v. every 3 weeks, both study arms
DRUG	Paclitaxel	175 mg/m2 i.v., every 3 weeks study arm A 155 mg/m2 i.v., every 3 weeks study arm B
DRUG	Capecitabine	1650 mg/m2 p.o. days 1-14 every 3 weeks study arm B

Timeline

• Start date: 2002-12-01
• Primary completion: 2006-06-01
• Completion: 2013-12-01
• First posted: 2011-09-14
• Last updated: 2015-09-17

Locations

9 sites across 1 country: Sweden