Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

This study has been terminated.
(Due to poor accrual)
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
First received: February 5, 2007
Last updated: February 12, 2013
Last verified: February 2013
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
Breast Cancer
Drug: Pegylated liposomal doxorubicin (Caelyx)
Drug: Epirubicin
Phase 2

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 II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Assessment of antitumor efficacy by objective tumor response rates [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile and tolerance between the two treatment arms [ Time Frame: Toxicity assessment of each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2003
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Epirubicin
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
Other Name: Farmorubicine
Experimental: 2
Drug: Pegylated liposomal doxorubicin (Caelyx)
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
Other Name: Caelyx

Detailed Description:
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:

  • Age 18-75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
  • Histologically- or cytologically- confirmed breast adenocarcinoma
  • No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
  • No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
  • At least 4 weeks interval since prior anticancer treatment
  • Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
  • Life expectancy > 3 months
  • Written informed consent

Exclusion Criteria:

  • Pregnancy or nursing
  • Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
  • Other invasive malignancy except nonmelanoma skin cancer or acute infection.
  • Radiation of measurable disease (except brain metastases)
  • Progressive brain metastases according to clinical or radiological criteria.
  • Brain metastases without prior radiation therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00431795

University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, 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
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
  More Information

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00431795     History of Changes
Other Study ID Numbers: CT/03.12 
Study First Received: February 5, 2007
Last Updated: February 12, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Advanced breast cancer
Pegylated liposomal doxorubicin

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 02, 2016