Phase 3
Completed N=218
Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim
Chemotherapy Associated Neutropenia · Breast Cancer
Source: ClinicalTrials.gov NCT01519700 ↗
Enrolled (actual)
218
Serious AEs
6.5%
Results posted
Apr 2015
Primary outcomePrimary: Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy — 1.17; 1.2 Days
Summary
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy |
1.17; 1.2 | — |
| SECONDARY Incidence of Febrile Neutropenia |
50; 49; 54; 51; 204; 2 | — |
| SECONDARY Number of Days of Fever |
39; 41; 42; 46; 168; 1 | — |
| SECONDARY Depth of Absolute Neutrophil Count Nadir |
0.808; 0.744; 0.776 | — |
| SECONDARY Time to Absolute Neutrophil Count Recovery |
2.0; 2.0; 2.0 | — |
| SECONDARY Frequency of Infections |
102; 104; 206; 1; 3; 4 | — |
| SECONDARY Incidence of Hospitalizations Due to Febrile Neutropenia |
50; 50; 55; 51; 206; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
- Women ≥ 18 years of age
- Estimated life expectancy of more than six months
Exclusion Criteria
- Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
- Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01519700). 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.