Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
- Conditions
- advanced or recurrent breast cancer
- Registration Number
- JPRN-UMIN000009090
- Lead Sponsor
- Saitama Breast Cancer Clinical Study Group (SBCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 70
Not provided
Only treatment with Bevacizumab planned case 4-1.Have hypersensitivity to Bevacizumab 4-2.During pregnancy or lactation 4-3.Patients receiving anticoagulant therapy 4-4.Daily treatment with hight-dose aspirin(>=325mg/day) or non-steroidal anti-inflammatory medications for chronic inflammatory disease 4-5.Bleeding tendency(including significant hemoptysis or pulmonary tumor cavitation and necrosis),(INR>=1.5 within two weeks prior to entry) 4-6.Uncontrolled peptic ucer 4-7.Perforation of gastrointestional tract within one year 4-8.Renal failure to treated,2+ or higher proteinuria within two weeks prior to entry 4-9.Uncontrolled hypertension 4-10.Clinically significant cardiovascular disease(>=Grade2 according to the Common Toxicity Criteria of the National Cancer Institute,version 4), clinically important echocardiographic findigs,or past or current history(within the last one year)of myocardial infarction 4-11.Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to treatment failure
- Secondary Outcome Measures
Name Time Method overall survival