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