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

May 19, 2015 updated by: Hellenic Oncology Research Group

A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

658

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University Hospital of Alexandroupolis Dept. of Medical Oncology
      • Athens, Greece
        • 401 Military Hospital of Athens
      • Athens, Greece
        • Air Forces Military Hospital of Athens
      • Athens, Greece
        • "IASO" General Hospital of Athens
      • Athens, Greece
        • "Agios Savvas" Anticancer Hospital of Athens
      • Athens, Greece
        • "Laikon" General Hospital
      • Athens, Greece
        • "Marika Iliadis" Hospital of Athens
      • Athens, Greece
        • "Metaxa's" Anticancer Hospital of Pireas
      • Larissa, Greece
        • State General Hospital of Larissa
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki
      • Thessaloniki, Greece
        • "AXEPA" General Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University Hospital of Heraklion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed breast adenocarcinoma.
  • Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
  • Absence of lymph node involvement after eclosion and hormone (E&H) staining and light microscopy evaluation.

  • Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:

    • Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);
    • Ki-67 + > 30%; Grade III; HER2 (3+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); Perineural infiltration or presence of tumor emboli in blood or lymph vessels.
  • Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
  • Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.
  • Absence of any clinical or radiological evidence of local or metastatic disease.
  • Age > 18 years.
  • Performance status (WHO) < 3.
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
  • Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
  • Adequate cardiac function (LVEF > 50%).
  • Negative pregnancy test.
  • Informed consent.

Exclusion Criteria:

  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
  • Other concurrent uncontrolled illness that could affect compliance with the study.
  • Psychiatric illness or social situation that would preclude study compliance.
  • Pregnant or nursing women.
  • History of allergic reaction attributed to docetaxel.
  • Other concurrent investigational agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Docetaxel
Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
Other Names:
  • Taxotere
Drug: Epirubicin
Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
Other Names:
  • Farmorubicin
Drug: Epirubicin
Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other Names:
  • Farmorubicin
Drug: Docetaxel
Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other Names:
  • Taxotere
Experimental: 2
Drug: Docetaxel
Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
Other Names:
  • Taxotere
Drug: Epirubicin
Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
Other Names:
  • Farmorubicin
Drug: Epirubicin
Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other Names:
  • Farmorubicin
Drug: Docetaxel
Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free interval between the two treatment arms
Time Frame: Five years
Five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of overall survival and safety between the two treatment arms
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Investigators

  • Principal Investigator: Dimitris Mavrudis, MD, University Hospital of Heraklion Dept. of Medical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 18, 2007

First Submitted That Met QC Criteria

January 18, 2007

First Posted (Estimate)

January 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/01.04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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