Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer
Summary
This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).
Timeline
- Start
- 2005-11-01
- Primary completion
- 2008-03-01
- Completion
- 2011-07-01
Outcome
Mixed primary results
registry Independent reader assessed ORR: 45 (33.6 to 55.9) percentage of participants NCT00274456 ↗
registry Independent reader assessed ORR: 49 (37.3 to 60.0) percentage of participants NCT00274456 ↗
registry analysis (unspecified test); ABI-007 300 mg/m^2 q3w vs ABI-007 100 mg/m^2 Weekly vs ABI-007 150 mg/m^2 Weekly vs Docetaxel 100 mg/m^2 q3w; p = 0.224 NCT00274456 ↗
paper but this did not reach statistical significance. PMID 19470941 ↗
paper This trend was supported by statistically significant investigator ORR for both weekly nab-paclitaxel doses versus docetaxel. PMID 19470941 ↗
Publications
- Background O'Shaughnessy J, Gradishar WJ, Bhar P, Iglesias J. Nab-paclitaxel for first-line treatment of patients with metastatic breast cancer and poor prognostic factors: a retrospective analysis. Breast Cancer Res Treat. 2013 Apr;138(3):829-37. doi: 10.1007/s10549-013-2447-8. Epub 2013 Apr 6.
- Results Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009 Aug 1;27(22):3611-9. doi: 10.1200/JCO.2008.18.5397. Epub 2009 May 26.
- Results Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P, McGuire JR, Iglesias J. Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: final analysis of overall survival. Clin Breast Cancer. 2012 Oct;12(5):313-21. doi: 10.1016/j.clbc.2012.05.001. Epub 2012 Jun 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABI-007 | Unknown | 100 mg/m2 | Intravenous |
| Subject | ABI-007 | Unknown | 150 mg/m2 | Intravenous |
| Subject | ABI-007 | Unknown | 300 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | — |