Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
- Registration Number
- NCT00467012
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description step 1 bevacizumab 6 enrollment for 1 cycle(4 weeks) step 2 bevacizumab 114 enrollment through to meet the stopping criteria step 1 Paclitaxel 6 enrollment for 1 cycle(4 weeks) step 2 Paclitaxel 114 enrollment through to meet the stopping criteria
- Primary Outcome Measures
Name Time Method Safety throughout study Progression-free survival (PFS) event driven
- Secondary Outcome Measures
Name Time Method Overall Survival(OS) event driven Time to Treatment Failure(TTF) evnt driven Response Rate(RR) event driven
Trial Locations
- Locations (5)
Kyushu region
🇯🇵Kyushu, Japan
Kanto Region
🇯🇵Kanto, Japan
Kinki Region
🇯🇵Kinki, Japan
Tohoku region
🇯🇵Tohoku, Japan
Sikoku region
🇯🇵Sikoku, Japan