Status:
COMPLETED
A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
Detailed Description
On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to ...
Eligibility Criteria
Inclusion
- Diagnosis of advanced breast cancer.
- Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
- ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Exclusion
- No prior treatment with cytotoxics in the advanced disease setting.
- HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
- Treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT00373256
Start Date
November 1 2006
End Date
August 1 2011
Last Update
September 10 2012
Active Locations (250)
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1
Pfizer Investigational Site
Bessemer, Alabama, United States, 35022
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
4
Pfizer Investigational Site
Birmingham, Alabama, United States, 35211