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Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

NCT00429871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2009-05-29

No results posted yet for this study

Summary

The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline

Conditions

Interventions

DRUG

Docetaxel

Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

DRUG

Capecitabine

Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles

DRUG

Epirubicin

Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

DRUG

Docetaxel

Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Dimitris Mavrudis, MD · University Hospital of Crete, Dep of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Greece

Study Locations

More Related Trials

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 NCT00429871 on ClinicalTrials.gov