SU11248 as Consolidation After Response to Taxanes in Metastatic Breast Cancer
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass
reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical
trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with
metastatic breast cancer after objective response to taxane chemotherapy. Patients randomized
to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248
treatment upon development of Response Evaluation Criteria in Solid Tumors (RECIST)-defined
disease progression.