Phase 3
Completed N=308
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Source: ClinicalTrials.gov NCT01516736 ↗Enrolled (actual)
308
Serious AEs
19.8%
Results posted
Jun 2017
Primary outcomePrimary: Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy — 1.36; 1.19; 1.34; 1.19 days — p=0.05
◆ Published Evidence
Emerging
14citations · ~2 / year
Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
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.
Linked Publications
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Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy |
1.36; 1.19; 1.34; 1.19 | 0.05 |
| SECONDARY Incidence of Febrile Neutropenia (FN) |
12; 15; 0; 3; 3; 1 | — |
| SECONDARY Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles |
13; 17; 8; 6; 4; 7 | — |
| SECONDARY Depth of ANC Nadir in Cycle 1 |
0.490; 0.444 | — |
| SECONDARY Number of Patients With ANC Nadir Per Day in Cycle 1 |
1; 0; 9; 8; 117; 109 | — |
| SECONDARY Time to ANC Recovery in Days in Cycle 1 |
2.11; 2.04 | — |
| SECONDARY Frequency of Infections by Cycle and Across All Cycles |
10; 14; 5; 3; 2; 5 | — |
| SECONDARY Mortality Due to Infection |
0; 0; 155; 153 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01516736) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.