Observational study to examine the efficacy of bevacizumab and paclitaxel combination therapy that targets inoperable or recurrent breast cancer
Not Applicable
- Conditions
- inoperable or recurrent breast cancer
- Registration Number
- JPRN-UMIN000010755
- Lead Sponsor
- PerSeUS:Perpetual Study estimated-by United Sections in Gifu
- Brief Summary
PFS (n=26 median ) 5.9M
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
1.Prior therapy with bevacizumab 2. Recurrence during adjuvant chemotherapy 3.History of hypersensitivity to the components of bevacizumab or paclitaxel 4.Women who are pregnant, lactating or declined contraception 5.Congestive heart failure, unstable angina, uncontrolled arrhythmia 6.Uncontrolled hypertension 7.Patients with ptoteinuria (>Grade2) 8.Arterial thromboembolism (stroke, myocardial infarction, etc.) 9.Venous thromboembolism (deep vein thrombosis, pulmonary embolism) 10.Gastrointestinal perforation or severe gastrointestinal fistula 11.Planned surgery within 4w prior to the study 12. nonhealing wound or fracture. 13.Patients considered ineligible by the attending physician
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Overall response rate, 1-year survival rate, 2-year survival rate, 3-year survival rate, Safety