Breast Cancer
Conditions
Keywords
breast cancer, chemotherapy, anti-angiogenesis therapy
Brief summary
To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without break plus bevacizumab as salvage treatment in patients with metastatic breast cancer.
Detailed description
Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone.
Interventions
DRUGVinorelbine
Vinorelbine per os 50 mg 3 times a week
DRUGBevacizumab
Bevacizumab 10 mg/kg IV every 14 days
Sponsors
University Hospital of Crete
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 * At least one previous chemotherapy regimen for metastatic breast cancer * Age 18-75 years * 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 function(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 upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function * No radiation of measurable disease (except brain metastases) * No progressive brain metastases according to clinical or radiological criteria * No brain metastases without prior radiation therapy * Written informed consent
Exclusion criteria
* Patient unable to take oral medication * Active infection * 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 |
|---|---|
| Response rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | 1 year |
| Progression free survival | 1 year |
| Overall survival | 1 year |
Countries
Greece
Outcome results
None listed