Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01519700 | Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim | PHASE3 | COMPLETED | 218 | — | — | Dec 1, 2011 | Jun 1, 2013 | May 6, 2015 | 26 | Czechia, Hungary +4 |
Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)
| Arm | Type | Description |
|---|---|---|
| EP2006 | EXPERIMENTAL | Eligible patients will be teated with EP2006 |
| Filgrastim | ACTIVE_COMPARATOR | Eligible patients will be teated with Filgrastim |
| Name | Type | Description |
|---|---|---|
| EP2006 | DRUG | Eligible patients will be teated with EP2006 |
| Filgrastim | DRUG | Eligible patients will be teated with Filgrastim |
Inclusion Criteria: 1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy 2. Women ≥ 18 years of age 3. Estimated life expectancy of more than six months Exclusion Criteria: 1. Previous or concurrent malignancy except non-invasive...