Clinical trial · Interventional
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®
A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
NCT01735175CI-TRIAL-00028962PROTECT-1completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Neutropenic Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LA-EP2006 | Drug | Pegfilgrastim | ALIAS |
| Neulasta® | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neulasta®
- description
- During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.
- interventionNames
- Drug: Neulasta®
- type
- EXPERIMENTAL
- label
- LA-EP2006
- description
- During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.
- interventionNames
- Drug: LA-EP2006
Primary outcomes (1)
- measure
- Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy
- timeFrame
- 21 days (Cycle 1 of chemotherapy treatment)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven breast cancer * eligible for six cycles of neoadjuvant or adjuvant chemotherapy Exclusion Criteria: * concurrent or prior chemotherapy for breast cancer * concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy * concurrent prophylactic antibiotics * previous therapy with any G-CSF (granulocyte-colony stimulating factor) product Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (2)
- RESULTHarbeck 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. PMID 27020170
- DERIVEDBlackwell 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. PMID 28637287