The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.
This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
Herceptin 8 mg/Kg (90 min IV) on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles over a 30 min IV
Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles
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
Time to progression (TTP) between the two treatment arms
Time frame: 1 year
Overall survival
Time frame: 1 year
Toxicity profile
Time frame: During the time of chemotherpy
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"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