A Phase 1/2 interventional study of Docetaxel and Epirubicin in Breast Cancer, sponsored by Hellenic Oncology Research Group. Completed at 10 sites in Greece. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-08-19.
Sponsored by Hellenic Oncology Research Group · Phase 1/2, Interventional, and Treatment
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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 46 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hellenic Oncology Research Group is the lead sponsor of 58 studies on the registry; none are open to participants now.
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Bevacizumab-\>Epirubicin-\>Docetaxel
Drug: Docetaxel · Drug: Epirubicin · Drug: Bevacizumab
Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles
Also known as: Taxotere
Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles
Also known as: Farmorubicine
Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles
Also known as: Avastin
Overall Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity assessment
Time frame: Toxicity assessment on each cycle
Time to Tumor Progression
Time frame: 1 year
Overall Survival
Time frame: 1 year
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Docetaxel · Epirubicin · Bevacizumab
Hellenic Oncology Research Group