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Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients

NCT00424606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2015-05-20

No results posted yet for this study

Summary

The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles

DRUG

Epirubicin

Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles

DRUG

Epirubicin

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

DRUG

Docetaxel

Docetaxel at the dose of 75 mg/m2 IV 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 Heraklion Dept. of Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Greece

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 NCT00424606 on ClinicalTrials.gov