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Brief Title: Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer
Official Title: Docetaxel-epirubicin Plus Bevacizumab as First Line Therapy for Patients With Metastatic and HER2 Negative Breast Cancer. A Multicenter Phase I-II Study
Study ID: NCT00705315
Brief Summary: This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.
Detailed Description: A phase II trial with 142 patients demonstrated that therapy with docetaxel plus epirubicin is highly active first-line therapy for metastatic breast cancer, with acceptable toxicity profile. Recently initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population.
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
University Hospital of Crete, Dep of Medical Oncology, Heraklion, , 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, Dep of Medical Oncology
Role: PRINCIPAL_INVESTIGATOR