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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00109239 |
This Phase III, multicenter, randomized, active-controlled, open-label trial is designed to evaluate the efficacy, safety, and pharmacokinetics of rhuMAb VEGF when combined with capecitabine compared with capecitabine alone in subjects with previously treated metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: rhuMAb VEGF (Bevacizumab) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Phase III, Randomized, Active-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of rhuMAb VEGF (Bevacizumab), in Combination With Capecitabine Chemotherapy, in Subjects With Previously Treated Metastatic Breast Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations other than in the breast within 7 days prior to Day 0; placement of a vascular access device within 7 days prior to Day 0
Pregnancy (positive pregnancy test) or lactation
Study ID Numbers: | AVF2119g |
Study First Received: | April 26, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00109239 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Breast Cancer Metastatic Cancer |
Capecitabine Skin Diseases Breast Neoplasms Bevacizumab 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 |