Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
NCT ID: NCT00467012
Last Updated: 2012-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2007-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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step 1
6 enrollment for 1 cycle(4 weeks)
bevacizumab
10mg/kg，Day1, 15 of 1 cycle(4 weeks)
Paclitaxel
90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)
step 2
114 enrollment through to meet the stopping criteria
bevacizumab
10mg/kg，Day1, 15 of 1 cycle(4 weeks)
Paclitaxel
90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)
Interventions
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bevacizumab
10mg/kg，Day1, 15 of 1 cycle(4 weeks)
Paclitaxel
90mg/ m2，Day1, 8, 15 of 1 cycle(4 weeks)
Eligibility Criteria
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Inclusion Criteria
* Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer
* HER2 negative
* At least one measurable lesion based on RECIST criteria
* No previous chemotherapy for metastatic breast cancer
20 Years
FEMALE
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Shingo Koganezawa
Role: STUDY_CHAIR
Clinical research department 3
Locations
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Kanto Region
Kanto, , Japan
Kinki Region
Kinki, , Japan
Kyushu region
Kyushu, , Japan
Sikoku region
Sikoku, , Japan
Tohoku region
Tōhoku, , Japan
Countries
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Other Identifiers
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JO19901
Identifier Type: -
Identifier Source: org_study_id
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