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Sponsored by: |
Genentech |
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 |
Breast Cancer |
Drug: rhuMAb VEGF (Bevacizumab) |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Capecitabine Bevacizumab |
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 Results 
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Study ID Numbers: | AVF2119g |
First Received: | April 26, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00109239 |
Health Authority: | United States: Food and Drug Administration |
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