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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01516736 | Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim | PHASE3 | COMPLETED | 308 | — | — | Mar 1, 2012 | Dec 1, 2013 | Aug 30, 2017 | 53 | United States, Argentina +6 |
Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).
| Arm | Type | Description |
|---|---|---|
| LA-EP2006 | EXPERIMENTAL | During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application. |
| Neulasta® | ACTIVE_COMPARATOR | During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application. |
| Name | Type | Description |
|---|---|---|
| LA-EP2006 | DRUG | Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application. |
| Neulasta® | DRUG | Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application. |
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, immunothera...