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Sponsored by: |
Abraxis BioScience Inc. |
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Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00394251 |
The primary objective of this study is to compare the safety of dose-dense Abraxane 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense AC chemotherapy. Bevacizumab will be administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Cytoxan Drug: Neulasta Drug: Bevacizumab Drug: ABI-007 Drug: Taxol Drug: Adriamycin Drug: ABI-007 plus Bevacizumab Drug: ABI-007 plus Bevacizuman Drug: ABI-007 plus Bevacizumag |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | An Open-Label, Randomized, Comparative Pilot Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ABI-007 plus Bevacizumab
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Drug: Cytoxan
With Adviamejcin every two weeks X4 cycles.
Drug: Neulasta
On D2 X8 cycles
Drug: Bevacizumab
10mg/kg every two weeks X8 cycles, then 15mg/kg every three weeks X10 doses
Drug: ABI-007
260mg/m2 IV every two weeks X4 cycles
Drug: Taxol
175mg/m2 every to weeks X4 cycles
Drug: Adriamycin
With Cyctoxan every two weeks X4 cycles
Drug: ABI-007 plus Bevacizumab
125mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: ABI-007 plus Bevacizuman
125mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: ABI-007 plus Bevacizumag
125mg1m^2,IV on days 1,8,15 of 28 day cycle
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2: Experimental
ABI-007 plus Bevacizumab
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Drug: ABI-007 plus Bevacizumab
125mg/m^2.IV on days 1,8,15 of 28 day cycle
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient will be eligible for inclusion in this study only if all of the following criteria are met:
T1b,c,N0M0 and ER or PR positive and grade 1 or 2 Tx tumors (regardless of nodal status) T4 disease [i.e., patients with fixed tumor, peau d'orange skin changes, skin ulcerations, or inflammatory changes
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
Responsible Party: | Abraxis BioScience ( Kristine Mayberry, Clinical Trials Manager ) |
Study ID Numbers: | CA045 |
Study First Received: | October 30, 2006 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00394251 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Adjuvant therapy bevacizumab abraxane Early Stage Breast Cancer |
Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Antimitotic Agents Cyclophosphamide Bevacizumab Angiogenesis Inhibitors Immunosuppressive Agents |
Doxorubicin Anti-Bacterial Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Breast Diseases Skin Diseases Growth Substances |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |