Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

PHASE3TerminatedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

April 30, 2003

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
Breast Cancer
Interventions
DRUG

Gemcitabine

Gemcitabine at the dose of 1250 mg/m2 IV on day 1 every 3 weeks for 6 cycles

DRUG

Herceptin

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

DRUG

Capecitabine (Xeloda)

Capecitabine at the dose of 1250 mg/m2 b.i.d p.o on day 1-14 every 3 weeks 6 cycles

Trial Locations (9)

Unknown

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli

"IASO General Hospital of Athens, 1st Dep of Medical Oncology", Athens

"Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine", Athens

"Marika Iliadis Hospital of Athens, Dep of Medical Oncology", Athens

401 Military Hospital of Athens, Athens

Air Forces Military Hospital of Athens, Athens

State General Hospital of Larissa, Dep of Medical Oncology, Larissa

"Metaxa's Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology", Piraeus

"Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology", Thessaloniki

All Listed Sponsors
collaborator

University Hospital of Crete

OTHER

lead

Hellenic Oncology Research Group

OTHER