Breast Cancer
Conditions
Keywords
breast cancer, chemotherapy, biological therapy
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.
Interventions
DRUGDocetaxel
Docetaxel as an IV infusion over 1h at the dose of 75mg/m2 every 3 weeks for 6 cycles
DRUGEpirubicin
Epirubicin as an IV infusion over 10 min at the dose of 75mg/m2 every 3 weeks for 6 cycles
DRUGBevacizumab
Bevacizumab as an IV infusion over 1h at the dose of 15 mg/kg every 3 weeks for 6 cycles
Sponsors
Hellenic Oncology Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity assessment | Toxicity assessment on each cycle |
| Time to Tumor Progression | 1 year |
| Overall Survival | 1 year |
Countries
Greece
Outcome results
None listed