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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01416389 | A Study of LY2523355 in Participants With Breast Cancer | PHASE2 | COMPLETED | 39 | — | — | Aug 1, 2011 | Sep 1, 2013 | Sep 18, 2019 | 12 | United States |
The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.
| Arm | Type | Description |
|---|---|---|
| LY2523355 + pegfilgrastim or filgrastim | EXPERIMENTAL | LY2523355: Five milligrams per meter squared per day (mg/m\^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met. |
| ixabepilone | ACTIVE_COMPARATOR | Forty milligrams per meter squared per day (mg/m\^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met. |
| Name | Type | Description |
|---|---|---|
| LY2523355 | DRUG | Administered intravenously as a one hour infusion |
| ixabepilone | DRUG | Administered intravenously |
| pegfilgrastim | DRUG | Administered intravenously |
| filgrastim | DRUG | Administered intravenously |
Inclusion Criteria: * Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent. * Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines. * Have received 2 or m...