Table 2 Statistical sample size calculation
Safety run-in | |
Numbers of subjects needed | 6 subjects |
Phase II trial | |
Primary endpoint achievement RCB 0/1 vs. RCB 2/3 | Standard arm: 15% |
Experimental arms: 45% | |
Hypothesis: increase in RCB 0/1 rates from 15 to 45% in either arm 2 or 3. | |
Alpha level (two-sided) | 2.5% |
Power | 80% |
Number of subjects needed | |
1:1:1 randomization | 44 subjects per arm, total of 132 subjects |
Increase for: | |
• 5% ineligible after randomisation | Add 15 subjects |
• 5% unevaluable subjects | 147 randomised subjects |
Increase for 20% ineligible after screening (MammaPrint genomic low risk). | Add 37 subjects. |
Total for phase 2 trial | 184 subjects screened |
Total evaluable subjects (safety run-in + phase II) | 136 subjects |