A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
Full 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 meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
488 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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