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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: | NCT00431795 |
DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Pegylated liposomal doxorubicin (Caelyx) Drug: Epirubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients |
Estimated Enrollment: | 182 |
Study Start Date: | June 2003 |
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: Experimental
Epi
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Drug: Epirubicin
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
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2: Experimental
Cael
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Drug: Pegylated liposomal doxorubicin (Caelyx)
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
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To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology | |
Athens, Greece | |
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
Athens, Greece | |
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | |
Piraeus, Greece | |
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology | |
Athens, 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 | |
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | |
Thessaloniki, Greece | |
Greece, Crete | |
University Hospital of Crete | |
Heraklion, Crete, Greece, 71110 |
Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete |
Responsible Party: | Hellenic Oncology Research Group ( D.Mavrudis ) |
Study ID Numbers: | CT/03.12 |
Study First Received: | February 5, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00431795 History of Changes |
Health Authority: | Greece: National Organization of Medicines |
Advanced breast cancer Pegylated liposomal doxorubicin Epirubicin |
Anti-Bacterial Agents Skin Diseases Breast Neoplasms |
Epirubicin Doxorubicin Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses Breast Neoplasms |
Antibiotics, Antineoplastic Epirubicin Pharmacologic Actions Doxorubicin Breast Diseases |