Due to poor accrual
A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients
Sponsor study identifier
interventional
100
1 country
10
Study Start
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 5, 2007
Actual (reported)February 6, 2007
Actual (reported)June 2012
Actual (reported)June 2012
Actual (reported)Assessment of antitumor efficacy by objective tumor response rates
Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
Toxicity profile and tolerance between the two treatment arms
Toxicity assessment of each chemotherapy cycle
Time to progression
1 year
Overall survival
1 year
Epi
Cael
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m\^2 IV every 4 weeks for 6 consecutive cycles
Epirubicin (Farmorubicin) at the dose of 90mg/m\^2 IV every 3 weeks for 6 consecutive cycles
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Pegylated liposomal doxorubicin (Caelyx)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordUniversity Hospital of Crete
Heraklion, Crete, 71110, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, 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
Dimitris Mavrudis, MD
University Hospital of Crete
100 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2007
First Posted
February 6, 2007
Study Start
June 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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
Primary Completion
June 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
February 13, 2013
Record last verified: 2013-02
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Source: ClinicalTrials.gov.
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