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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431795
Recruitment Status : Terminated (Due to poor accrual)
First Posted : February 6, 2007
Last Update Posted : February 13, 2013
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Pegylated liposomal doxorubicin (Caelyx) Drug: Epirubicin Phase 2

Detailed Description:
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2003
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Assessment of antitumor efficacy by objective tumor response rates [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy) ]

Secondary Outcome Measures :
  1. Toxicity profile and tolerance between the two treatment arms [ Time Frame: Toxicity assessment of each chemotherapy cycle ]
  2. Time to progression [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431795

University Hospital of Crete
Heraklion, Crete, Greece, 71110
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
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
"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

Responsible Party: Hellenic Oncology Research Group Identifier: NCT00431795     History of Changes
Other Study ID Numbers: CT/03.12
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

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

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