A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)
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ClinicalTrials.gov Identifier: NCT00281697 |
Recruitment Status
:
Completed
First Posted
: January 25, 2006
Results First Posted
: September 24, 2012
Last Update Posted
: July 26, 2013
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | January 23, 2006 | |||
First Posted Date ICMJE | January 25, 2006 | |||
Results First Submitted Date | August 23, 2012 | |||
Results First Posted Date | September 24, 2012 | |||
Last Update Posted Date | July 26, 2013 | |||
Study Start Date ICMJE | February 2006 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-free Survival [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ] PFS was defined as the time from randomization to first documented disease progression (PD) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
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Original Primary Outcome Measures ICMJE |
To determine the clinical benefit of the addition of bevacizumab to standard chemotherapy for previously treated metastatic breast cancer (MBC), as measured by progression-free survival (PFS). | |||
Change History | Complete list of historical versions of study NCT00281697 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
To evaluate the efficacy and safety of bevacizumab when combined with chemotherapy compared with chemotherapy alone in subjects receiving second-line therapy for MBC, as measured by Overall survival and Objective response. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2) | |||
Official Title ICMJE | A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer | |||
Brief Summary | This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy compared with chemotherapy alone in subjects with previously treated metastatic breast cancer. | |||
Detailed Description | For all Outcome Measures except Overall Survival and One-year Survival, the Time Frame was from Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years 2 months). For the Outcome Measures Overall Survival and One-year Survival, the Time Frame was from Baseline to the end of the study (up to 6 years, 7 months). | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Breast Cancer | |||
Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
684 | |||
Original Enrollment ICMJE |
630 | |||
Actual Study Completion Date | September 2012 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Australia, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Former Serbia and Montenegro, France, Italy, Latvia, Malaysia, Philippines, Romania, Russian Federation, Serbia, Singapore, South Africa, Spain, Thailand, Ukraine, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00281697 | |||
Other Study ID Numbers ICMJE | AVF3693g | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Genentech, Inc. | |||
Study Sponsor ICMJE | Genentech, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Genentech, Inc. | |||
Verification Date | July 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |