|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00394251 |
Purpose
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 |
|---|---|---|
|
Breast Cancer |
Drug: Cytoxan Drug: Neulasta Drug: Bevacizumab Drug: ABI-007 Drug: Taxol Drug: Adriamycin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 203 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Adriamycin and Cytoxan plus 260mg/m2 ABI-007 (Abraxane) every two weeks plus Bevacizumab
|
Drug: Cytoxan
With Adriamycin 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: Adriamycin
With Cyctoxan every two weeks X4 cycles
|
|
Experimental: 2
Adriamycin and Cytoxan plus 175mg/m2 Taxol plus Bevacizumab
|
Drug: Bevacizumab
10mg/kg every two weeks X8 cycles, then 15mg/kg every three weeks X10 doses
Drug: Taxol
175mg/m2 every to weeks X4 cycles
|
Eligibility| 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:
-Note: the following are not eligible-
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:
Contacts and Locations
Show 27 Study Locations
More Information
| Responsible Party: | Pankaj Patel, Clinical Trials Manager, Abraxis BioScience |
| ClinicalTrials.gov Identifier: | NCT00394251 History of Changes |
| Other Study ID Numbers: | CA045 |
| Study First Received: | October 30, 2006 |
| Last Updated: | May 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Adjuvant therapy bevacizumab abraxane Early Stage Breast Cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Cyclophosphamide Bevacizumab Doxorubicin Paclitaxel Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antirheumatic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |