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Table 1 Baseline demographics and disease characteristics for the ITT population and the correlative cohort

From: PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial

Characteristic ITT population (n = 2840) Correlative cohort (n = 1201)
Neratinib (n = 1420) Placebo (n = 1420) Neratinib (n = 593) Placebo (n = 608)
Median age, years (range) 52 (25–83) 52 (23–82) 53 (26–83) 53 (26–81)
Menopausal status at diagnosis, n (%)
 Premenopausal 663 (46.7) 664 (46.8) 277 (46.7) 267 (43.9)
 Postmenopausal 757 (53.3) 756 (53.2) 316 (53.3) 341 (56.1)
Prior trastuzumab, n (%)
 Concurrent to chemotherapy 884 (62.3) 886 (62.4) 374 (63.1) 400 (65.8)
 Sequential after chemotherapy 536 (37.7) 534 (37.6) 219 (36.9) 208 (34.2)
Median time since trastuzumab, months (range) 4.4 (0.2–30.9) 4.6 (0.3–40.6) 4.9 (0.3–24.0) 6.5 (0.4–24.2)
Median time from diagnosis to randomization (range), months 21.82 (7.69–73.69) 22.29 (7.82–103.03) 22.44 (7.79–73.69) 23.64 (7.82–66.96)
Nodal status, n (%)
 Negative 335 (23.6) 336 (23.7) 160 (27.0) 177 (29.1)
 1–3 positive nodes 664 (46.8) 664 (46.8) 265 (44.7) 266 (43.8)
 ≥ 4 positive nodes 421 (29.6) 420 (29.6) 168 (28.3) 165 (27.1)
Hormone receptor status, n (%)
 Positive 816 (57.5) 815 (57.4) 339 (57.2) 361 (59.4)
 Negative 604 (42.5) 605 (42.6) 254 (42.8) 247 (40.6)