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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: | NCT00431106 |
The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline. Capecitabine rescue monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline, also seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients. Whether the combination of vinorelbine and gemcitabine or capecitabine administration is preferable is not yet known, especially in patients with metastatic disease.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Gemcitabine Drug: Capecitabine Drug: Vinorelbine |
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 Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline |
Estimated Enrollment: | 144 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Vinorelbine/Gemcitabine (VG)
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Drug: Gemcitabine
Gemcitabine at the dose of 1000 mg/m2 intravenously (IV) every 2 weeks for 12 consecutive cycles
Drug: Vinorelbine
Vinorelbine at the dose of 25 mg/m2 IV on day 1 every 2 weeks for 12 consecutive cycles
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2: Active Comparator
Capecitabine (Cap)
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Drug: Capecitabine
Capecitabine at the dose of 1250 mg/m2 twice daily orally (os), from day 1 to day 14, every 3 weeks for 6 consecutive cycles
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This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the combination of a taxane and an anthracycline.
Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Eva Maragkoudaki | +30281392857 | dorachat@med.uoc.gr |
Greece | |
"Marika Iliadis" Hospital of Athens, Dept. of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Malamos, MD | |
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Aris Polyzos, MD | |
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology | Recruiting |
Piraeus, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Nikos Ziras, MD | |
"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology | Recruiting |
Athens, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Stelios Giassas, 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 | |
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 | |
State General Hospital of Larissa, Dept. of Medical Oncology | Recruiting |
Larissa, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Athanasios Athanasiadis, MD | |
University General 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 | |
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dept. of Medical Oncology | Recruiting |
Thessaloniki, Greece | |
Contact: George Tavoularis +302106457968 secretary@horg.gr | |
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr | |
Principal Investigator: Ioannis Boukovinas, MD | |
Greece, Crete | |
University Hospital of Crete | Recruiting |
Heraklion, Crete, Greece, 71110 | |
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
Principal Investigator: Dimitris Mavrudis, MD |
Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete |
Responsible Party: | Hellenic Oncology Research Group ( D. Mavrudis ) |
Study ID Numbers: | CT/02.11 |
Study First Received: | February 2, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00431106 History of Changes |
Health Authority: | Greece: National Organization of Medicines |
Breast cancer Chemotherapy Vinorelbine Gemcitabine Capecitabine |
Antimetabolites Capecitabine Skin Diseases Immunologic Factors Breast Neoplasms Antiviral Agents Immunosuppressive Agents |
Vinorelbine Radiation-Sensitizing Agents Gemcitabine Taxane Antineoplastic Agents, Phytogenic Breast Diseases |
Antimetabolites Anti-Infective Agents Capecitabine Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Vinorelbine Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine Antineoplastic Agents, Phytogenic Breast Diseases |