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Sponsors and Collaborators: |
Genentech Hoffmann-La Roche |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00262067 |
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.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: bevacizumab Drug: chemotherapy Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | 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 |
Estimated Enrollment: | 1200 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Repeating dose
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2: Placebo Comparator |
Drug: chemotherapy
Repeating dose
Drug: placebo
Intravenous repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genentech, Inc. ( See Phan, M.D., Study Director ) |
Study ID Numbers: | AVF3694g, BO20094 |
Study First Received: | December 2, 2005 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00262067 |
Health Authority: | United States: Food and Drug Administration |
MBC Breast Cancer Avastin Adenocarcinoma |
Skin Diseases Breast Neoplasms Bevacizumab Adenocarcinoma Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |