Table 4.
Phase III trials with cyclin-dependent kinase4/6 in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer: inclusion criteria
| PALOMA-2 (%) | PALOMA-3 (%) | MONALEESA-2 (%) | MONARCH 3 (%) | MONARCH 2 (%) | ||||||
| Palbociclib + Letrozol |
Placebo + Letrozol |
Palbociclib + Fulvestrant |
Placebo + Fulvestrant |
Ribociclib + Letrozol |
Placebo + Letrozol |
Abemaciclib + NSAI |
Placebo + NSAI |
Abemaciclib + Fulvestrant |
Placebo + Fulvestrant |
|
| Menopausal status | ||||||||||
| Pre/perimenopausal | 0 | 0 | 21 | 21 | 0 | 0 | 0 | 0 | 16 | 19 |
| Postmenopausal | 100 | 100 | 79 | 79 | 100 | 100 | 100 | 100 | 83 | 81 |
| Gender | ||||||||||
| Female | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Disease-free interval | ||||||||||
| Newly metastatic | 38 | 36 | 0 | 0 | 34 | 34 | 41 | 37 | na | na |
| <12 months | 22 | 22 | 5 | 2 | 1 | 3 | na | na | ||
| >12 months | 40 | 42 | 95 | 98 | 65 | 63 | na | na | ||
| Treatment-free interval | ||||||||||
| <36 months | na | na | na | na | na | na | 28 | 40 | na | na |
| ≥36 months | 63 | 50 | ||||||||
| unknown | 9 | 10 | ||||||||
| Prior neo-/adjuvant chemotherapy | 48 | 49 | 40 | 43 | 44 | 43 | 38 | 40 | 60 | 60 |
| Prior therapies for advanced BC | ||||||||||
| 1 | 0 | 0 | 38 | 40 | 0 | 0 | 0 | 0 | 38 | 38 |
| >2 (%) | 0 | 0 | 38 | 34 | 0 | 0 | 0 | 0 | 0 | 0 |
na, not available; NSAI, non-steroidal aromatase inhibitor.