Conditions: Breast Neoplasms
Keywords: metastatic breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 174
Healthy volunteers: no

Brief summary:
The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Detailed description:

Arms:
arm 1: Docetaxel + Placebo arm 2: Docetaxel + AG-013736

Interventions: intervention 1: Placebo intervention 2: Docetaxel intervention 3: AG-013736 (axitinib) intervention 4: Docetaxel
Intervention descriptions: intervention 1: 5 mg twice daily \[bid\] continuous dosing intervention 2: Standard of care drug administration intervention 3: 5mg twice daily \[bid\] continuous dosing intervention 4: Standard of care drug administration

Protocol document: