Status:
COMPLETED
Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00705315
Start Date
May 1 2008
End Date
June 1 2010
Last Update
August 19 2010
Active Locations (10)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece