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Brief Title: Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Official Title: A Multicenter Randomized Phase III Study of Gemcitabine Plus Herceptin Combination Versus the Capecitabine Plus Herceptin Combination in Pretreated Patients With HER-2 Positive Metastatic Breast Cancer
Study ID: NCT00440622
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Dimitris Mavrudis, MD
Affiliation: University Hospital of Crete
Role: PRINCIPAL_INVESTIGATOR