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A Multicenter, Phase III, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Untreated Metastatic Breast Cancer
This is a Phase III, multicenter, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of bevacizumab in combination with chemotherapy compared with chemotherapy alone in subjects with previously untreated metastatic breast cancer.
Details
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 1237 |
| Start date | 2005-12 |
| Completion | 2013-12 |
Conditions
- Metastatic Breast Cancer
Interventions
- Bevacizumab
- Placebo
- Chemotherapy
Primary outcomes
- Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) — Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 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.
Countries
United States, Australia, Brazil, Canada, France, Greece, Guatemala, Mexico, Netherlands, Norway, Panama, Peru, Philippines, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom, Uruguay