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
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
University Hospital of Crete
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Assessment of antitumor efficacy by objective tumor response rates
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
Toxicity profile and tolerance between the two treatment arms
Time frame: Toxicity assessment of each chemotherapy cycle
Time to progression
Time frame: 1 year
Overall survival
Time frame: 1 year
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"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