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