drugset / Trial / NCT01735175
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Timeline
- Start
- 2012-06
- Primary completion
- 2013-05
- Completion
- 2014-02
Publications
- Results Harbeck N, Lipatov O, Frolova M, Udovitsa D, Topuzov E, Ganea-Motan DE, Nakov R, Singh P, Rudy A, Blackwell K. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016 Jun;12(11):1359-67. doi: 10.2217/fon-2016-0016. Epub 2016 Mar 29.
- Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LA-EP2006 | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | — | Subcutaneous |