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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00429871 |
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
Condition | Intervention | Phase |
Breast Cancer |
Drug: Docetaxel Drug: Capecitabine Drug: Epirubicin |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Docetaxel Capecitabine Epirubicin hydrochloride Epirubicin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer |
Estimated Enrollment: | 272 |
Study Start Date: | May 2002 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
DF
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Drug: Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Drug: Epirubicin
Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
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2: Experimental
DC
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Drug: Capecitabine
Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
Drug: Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
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This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC
Ages Eligible for Study: | 19 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |||||
401 Military Hospital of Athens | |||||
Athens, Greece | |||||
Air Forces Military Hospital of Athens | |||||
Athens, Greece | |||||
State General Hospital of Larissa, Dep of Medical Oncology | |||||
Larissa, Greece | |||||
University General Hospital of Alexandroupolis, Dep of Medical Oncology | |||||
Alexandroupolis, Greece | |||||
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology | |||||
Athens, Greece | |||||
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |||||
Athens, Greece | |||||
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology | |||||
Athens, Greece | |||||
"Metaxa's" Anticancer Hospital of Piraias | |||||
Piraeus, Greece | |||||
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | |||||
Thessaloniki, Greece | |||||
Greece, Crete | |||||
University Hospital of Heraklion | |||||
Heraklion, Crete, Greece, 71110 |
Hellenic Oncology Research Group |
University Hospital of Crete |
Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete, Dep of Medical Oncology |
Responsible Party: | Hellenic Oncology Research Group ( D.Mavrudis ) |
Study ID Numbers: | CT/02.09 |
First Received: | January 31, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00429871 |
Health Authority: | Greece: National Organization of Medicines |
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