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Sponsored by: |
Abraxis BioScience Inc. |
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Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00394082 |
The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab.
The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: ABI-007 plus Bevacizumab Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Weekly Administration of ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ABI-007 plus Bevacizumab: Experimental |
Drug: ABI-007 plus Bevacizumab
125 mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: Bevacizumab
10mg/kg given every 2 weeks beginning Cycle 1, Day 1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.
United States, Florida | |
Ocoee, Florida, United States, 34761 | |
Melbourne, Florida, United States, 32901 | |
United States, Illinois | |
Niles, Illinois, United States, 60714 | |
United States, Indiana | |
Terre Haute, Indiana, United States, 47802 | |
United States, Maryland | |
Columbia, Maryland, United States, 21044 | |
Westminister, Maryland, United States, 21157 | |
United States, Missouri | |
St. Joseph, Missouri, United States, 64507 | |
United States, New York | |
Rochester, New York, United States, 14623 | |
United States, Texas | |
Denton, Texas, United States, 76210 | |
Tyler, Texas, United States, 75702 | |
Odessa, Texas, United States, 79761 | |
Bedford, Texas, United States, 76022 | |
El Paso, Texas, United States, 79915 | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Roanoke, Virginia, United States, 24014 | |
Norfolk, Virginia, United States, 23502 | |
Fairfax, Virginia, United States, 22031 | |
United States, Washington | |
Edmonds, Washington, United States, 98026 | |
Seattle, Washington, United States, 98133 | |
Vancouver, Washington, United States, 98684 |
Responsible Party: | Abraxis BioScience ( Kristine Mayberry, Clinical Trials Manager ) |
Study ID Numbers: | CA043 |
Study First Received: | October 30, 2006 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00394082 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic breast cancer, Abraxane, Bevacizumab |
Skin Diseases Paclitaxel Breast Neoplasms |
Bevacizumab Angiogenesis Inhibitors Breast Diseases |
Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Bevacizumab Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Breast Diseases |