Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer (SUN 1064)
Tracking Information
Start Date ICMJE | February 2007 |
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Primary Completion Date | September 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 21, 2007) | Progression free survival - Radiographic progression of disease [ Time Frame: From screening until disease progression ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: October 30, 2006) | Progression-free survival |
Change History | Complete list of historical versions of study NCT00393939 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 21, 2007) |
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Original Secondary Outcome Measures ICMJE (submitted: October 30, 2006) | Overall survival Overall response rate Duration of response Patient reported outcome changes Overall safety profile. |
Descriptive Information
Brief Title ICMJE | Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer |
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Official Title ICMJE | A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients |
Brief Summary | This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Breast Neoplasms |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
stimated Enrollment ICMJE | 550 | ||||||||
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Estimated Completion Date | January 2012 | ||||||||
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Finland, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, Panama, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00393939 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | ||||
Study ID Numbers ICMJE | A6181064 | ||||
Study Sponsor ICMJE | Pfizer | ||||
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Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/