Conditions: Breast Cancer
Keywords: Early Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 384
Healthy volunteers: no

Brief summary:
The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ixabepilone intervention 2: Paclitaxel intervention 3: Cyclophosphamide intervention 4: Doxorubicin
Intervention descriptions: intervention 1: Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks intervention 2: Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks intervention 3: Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks intervention 4: Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks

Protocol document: