Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.

Detailed description:

Arms:
arm 1: Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.

Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A). arm 2: Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.

Interventions: intervention 1: Enzastaurin intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Placebo
Intervention descriptions: intervention 1: 1125 milligrams (mg) loading dose on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression intervention 2: 10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression intervention 3: 90 milligrams per square meter (mg/m\^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression intervention 4: Oral, daily, until disease progression

Protocol document: