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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
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Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00424606 |
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 |
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Breast Cancer |
Drug: Docetaxel Drug: Epirubicin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 724 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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
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2: Experimental |
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
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Sofia Mavraki | +302810392987 |
Greece | |
"Laikon" General Hospital | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Aris Polyzos, MD | |
"Marika Iliadis" Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Malamos, MD | |
"Metaxa's" Anticancer Hospital of Pireas | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Ziras, MD | |
Air Forces Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Kentepozidis, MD | |
401 Military Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Charalampos Christophillakis, MD | |
"IASO" General Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Giassas, MD | |
"Agios Savvas" Anticancer Hospital of Athens | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Alekos Ardavanis, MD | |
State General Hospital of Larissa | Recruiting |
Larissa, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athanasios Athanasiadis, MD | |
"Theagenion" Anticancer Hospital of Thessaloniki | Recruiting |
Thessaloniki, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Ioannis Boukovinas, MD | |
"AXEPA" General Hospital of Thessaloniki | Recruiting |
Thessaloniki, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Paris Makrantonakis, MD | |
University Hospital of Alexandroupolis Dept. of Medical Oncology | Recruiting |
Alexandroupolis, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Kakolyris, MD | |
Greece, Crete | |
University Hospital of Heraklion | Recruiting |
Heraklion, Crete, Greece, 71110 | |
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
Principal Investigator: Dimitris Mavrudis, MD |
Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Heraklion Dept. of Medical Oncology |
Responsible Party: | Hellenic Oncology Research Group ( V. Georgoulias ) |
Study ID Numbers: | CT/01.04 |
Study First Received: | January 18, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00424606 |
Health Authority: | Greece: National Organization of Medicines |
High risk node negative |
Docetaxel Skin Diseases Breast Neoplasms Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |