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Brief Title: Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Official Title: A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
Study ID: NCT00453635
Brief Summary: This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
Detailed Description: Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University Hospital of Crete, Heraklion, Crete, Greece
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
401 Military Hospital of Athens, Athens, , Greece
Air Forces Military Hospital of Athens, Athens, , Greece
Marika Iliadis" Hospital of Athens, Dep of Medical Oncology, Athens, , Greece
State General Hospital of Larissa, Athens, , 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 Mavroudis, MD
Affiliation: University Hospital of Crete, Dep of Medical Oncology
Role: PRINCIPAL_INVESTIGATOR