The purpose of this study is to evaluate the efficacy and safety of the combination of biweekly docetaxel and bevacizumab in the first line treatment of metastatic breast cancer by using Response Evaluation Criteria In Solid Tumors (RECIST criteria) and NCI Common Terminology Criteria for Adverse Events (NCI CTC-AE) version 3. In addition several biochemical makers are tested as possible predictive factors.
Patients with histologically or cytologically proven measurable or nonmeasurable metastatic breast cancer are treated with a combination of biweekly docetaxel and bevacizumab as the first line treatment in multicenter phase II trial. The outcome measures would be PFS, Response rate (RECIST), duration of response, safety (NCI CTC-AE version 3) and survival. In addition several biochemical makers are tested as possible predictive factors. Treatment would be continued until PD, patient's refusal or treatment discontinuation due to side-effects or patients death. In responding patients bevacizumab would be continued either alone or in hormone receptor positive patients combined with hormone treatment until progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Tampere Unviersity Hospital
Tampere, Finland
progression free survival
increase of cancer burden
Time frame: 1-3 months
efficacy, changes in metastacic lesions
response rate
Time frame: every 2 months
overall survival
alive
Time frame: 2- 3 months
time to response
decrease of cancer burden
Time frame: 2 months
duration of response
gain
Time frame: 2 months
progression free survival from first relapse
second increase of cancer burden
Time frame: 2 months
safety, occurence of side-effects
side effects according to NCICTC-AE version 3.0
Time frame: 1 month
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