Conditions: Breast Neoplasms
Keywords: advanced breast cancer metastatic breast cancer treatment resistant treatment failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 482
Healthy volunteers: no

Brief summary:
To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Detailed description:
Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Arms:
arm 1: 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles arm 2: 37.5 mg daily, continuous dosing

Interventions: intervention 1: Capecitabine intervention 2: Sunitinib malate
Intervention descriptions: intervention 1: 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles intervention 2: 37.5 mg daily, continuous dosing

Protocol document: