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

NCT01433614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2015-09-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Thomas Hatschek

    lead OTHER

Principal Investigators

  • Thomas Hatschek, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2006-06-30
Completion
2013-12-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433614 on ClinicalTrials.gov