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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00281528 |
Purpose
This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to a 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Neoplasm Metastasis |
Drug: ABI-007 (Abraxane) and Bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Weekly Versus Every 2-week Versus Every 3-week Administration of ABI-007 (Abraxane) in Combination With Bevacizumab in Women With Metastatic Breast Cancer. |
| Enrollment: | 212 |
| Study Start Date: | February 2006 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Every 3-week ABI-007 plus Bevacizumab
|
Drug: ABI-007 (Abraxane) and Bevacizumab
Treatment with various schedules ABI-007 and Bevacizumab
|
|
Experimental: 2
Every 2-week ABI-007 Plus Bevacizumab
|
Drug: ABI-007 (Abraxane) and Bevacizumab
Treatment with various schedules ABI-007 and Bevacizumab
|
|
Experimental: 3
Weekly ABI-007 plus Bevacizumab
|
Drug: ABI-007 (Abraxane) and Bevacizumab
Treatment with various schedules ABI-007 and Bevacizumab
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ANC ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; Hgb ≥ 9 g/dL.
Exclusion Criteria:
Contacts and Locations
Show 40 Study Locations| Principal Investigator: | Andrew Seidman, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Doria Schofield, Clinical Trials Manager, Abraxis BioScience |
| ClinicalTrials.gov Identifier: | NCT00281528 History of Changes |
| Other Study ID Numbers: | CA023 |
| Study First Received: | January 24, 2006 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
First Line Metastatic Breast Cancer |
|
Breast Neoplasms Neoplasms Neoplasm Metastasis Neoplasms by Site Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Paclitaxel Bevacizumab Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |