Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Oral Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane
I. Determine the tumor response rate in patients with metastatic breast cancer previously
treated with an anthracycline- and/or taxane-containing regimen receiving sorafenib.
II. Assess the toxicity profile of this drug in these patients. III. Determine time to
disease progression and survival time of patients treated with this drug.
IV. Correlate pre-treatment levels of activated ERK1/2 with tumor response in patients
treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months until disease progression and then every 3 months for
up to 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of confirmed tumor responses, graded according to RECIST criteria
A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. The tumor response rate is defined as the total number of eligible patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of eligible patients enrolled on study. A 90% confidence interval for the true response rate will be constructed using the Duffy-Santner approach.
Up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
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