Trial Information
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer
Inclusion Criteria
- At least 20 years old and obtained a written informed consent
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Outcome Time Frame:
throughout study
Safety Issue:
Yes
Principal Investigator
Shingo Koganezawa
Investigator Role:
Study Chair
Investigator Affiliation:
Clinical research department 3
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JO19901
NCT ID:
NCT00467012
Start Date:
April 2007
Completion Date:
September 2011
Related Keywords:
- Metastatic Breast Cancer
- Inoperable metastatic breast cancer
- Breast Neoplasms