A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- breast adenocarcinoma
- prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting
Exclusion criteria
- Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
- Any prior regimen with capecitabine
Trial design
Primary purpose
Allocation
Interventional model
Masking
482 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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