Conditions: Metastatic Breast Cancer
Keywords: Locally Recurrent Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: LY2523355 intervention 2: ixabepilone intervention 3: pegfilgrastim intervention 4: filgrastim
Intervention descriptions: intervention 1: Administered intravenously as a one hour infusion intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously

Protocol document: