S1207 An Upcoming Trial for High-Risk Breast Cancer - SWOG

4/22/2013
S1207 Statistical Considerations
• Randomize 3,500 patients over 3.5 years
• 90% power (with 2-sided α=0.05) to
detect an effective hazard ratio of 0.75
for everolimus vs placebo, corresponding
to a gain in IDFS of approximately 4.3%
at 5 years
• All patients will be followed for 10 years
to assess OS and late adverse events
• Expected trial duration from activation to
reporting of IDFS is about 7 years
S1207 Statistical Considerations
• Primary analysis will be a stratified log-rank test
of treatment effect on IDFS with stratification on
the 4 risk levels.
◦ Interaction between treatment and risk level
◦ Separate subset analyses are planned for node+ and
node- patients
• 295 event are expected in the standard treatment
arm.
◦ 1 st interim analysis would be after 39% of the events
in the control arm have been observed (3.5 years
after initiation.
◦ There will be annual interim analysis (60 and 801%
expected events) with final analysis 3 years after last
patient was enrolled or 6.5 years after activation.
Study calendar
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