A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer
NCT00373256
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer | |||
Official Title ICMJE | A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer | |||
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 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 488 | |||
Original Enrollment ICMJE | 740 | |||
Actual Study Completion Date ICMJE | August 2011 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, Italy, Spain, United States | |||
Removed Location Countries | Puerto Rico | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00373256 | |||
Other Study ID Numbers ICMJE | A6181094 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |