Table 3.

FDA's analysis of IDFS, in the ITT population of APHINITY

Chemotherapy, trastuzumab and pertuzumab N = 2,400, n (%)Chemotherapy, trastuzumab and placebo N = 2,404, n (%)
IDFS events (n)171 (7.1%)210 (8.7%)
Distant recurrence112139
Locoregional recurrence2634
Contralateral breast cancer511
Death without prior IDFS events2826
3-yr IDFS rate (95% CI)94.06% (93.09–95.03)93.24% (92.21–94.26)
Stratified HR (95% CI)a0.82 (0.67–1.00)
Stratified log-rank P valuea0.047
  • Abbreviation: yr, year.

  • aStratified by randomization stratification factors collected from IxRS: nodal status, hormone receptor status, chemotherapy regimen, and protocol version.