Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00705315
- Lead Sponsor
- Hellenic Oncology Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
- No HER2 overexpression or gene amplification
- No previous therapy for metastatic breast cancer is allowed
- Age 18-75 years
- At least 12 months interval since prior adjuvant therapy with taxanes and/or anthracyclines
- Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
- Performance status (WHO) 0-2
- Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases)
- Adequate renal function (serum creatinine <1.5 times the upper normal limit
- Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- Written informed consent
- Active infection
- Brain metastases
- History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- History of stroke
- Anticoagulation therapy (except of low dose aspirin <325mg)
- Other invasive malignancy except nonmelanoma skin cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Epirubicin Bevacizumab-\>Epirubicin-\>Docetaxel 1 Docetaxel Bevacizumab-\>Epirubicin-\>Docetaxel 1 Bevacizumab Bevacizumab-\>Epirubicin-\>Docetaxel
- Primary Outcome Measures
Name Time Method Overall Response Rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
- Secondary Outcome Measures
Name Time Method Toxicity assessment Toxicity assessment on each cycle Time to Tumor Progression 1 year Overall Survival 1 year
Trial Locations
- Locations (10)
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
🇬🇷Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
🇬🇷Larissa,, 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
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
🇬🇷Piraeus, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
University Hospital of Crete, Dep of Medical Oncology
🇬🇷Heraklion, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
🇬🇷Thessaloniki, Greece