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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00424606
First received: January 18, 2007
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Epirubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Disease-free interval between the two treatment arms [ Time Frame: Five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of overall survival and safety between the two treatment arms [ Time Frame: Five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 724
Study Start Date: April 2002
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Docetaxel
Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
Other Name: Taxotere
Drug: Epirubicin
Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
Other Name: Farmorubicin
Experimental: 2 Drug: Epirubicin
Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other Name: Farmorubicin
Drug: Docetaxel
Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other Name: Taxotere

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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+);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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424606

Locations
Greece
University Hospital of Heraklion
Heraklion, Crete, Greece, 71110
University Hospital of Alexandroupolis Dept. of Medical Oncology
Alexandroupolis, Greece
Air Forces Military Hospital of Athens
Athens, Greece
"IASO" General Hospital of Athens
Athens, Greece
"Laikon" General Hospital
Athens, Greece
"Marika Iliadis" Hospital of Athens
Athens, Greece
"Metaxa's" Anticancer Hospital of Pireas
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
"Agios Savvas" Anticancer Hospital of Athens
Athens, Greece
State General Hospital of Larissa
Larissa, Greece
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
"AXEPA" General Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Heraklion Dept. of Medical Oncology
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00424606     History of Changes
Other Study ID Numbers: CT/01.04
Study First Received: January 18, 2007
Last Updated: November 3, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
High risk node negative

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Epirubicin
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014