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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00281697 |
Purpose
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 MBC.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: bevacizumab Drug: chemotherapy Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 650 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Repeating dose
|
| Placebo Comparator: 2 |
Drug: chemotherapy
Repeating dose
Drug: placebo
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 312 Study Locations| Study Director: | Jai Balkissoon, M.D. | Genentech |
More Information
| Responsible Party: | Jai Balkissoon, M.D., Study Director, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00281697 History of Changes |
| Other Study ID Numbers: | AVF3693g |
| Study First Received: | January 23, 2006 |
| Last Updated: | September 22, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Ribbon 2 Avastin MBC Breast Cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bevacizumab Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |