Table I.
Key clinical trials on CDK4/6 inhibitors in patients with hormone receptor+/human epidermal growth factor receptor 2− advanced breast cancer/metastatic breast cancer.
| NCT | Study name | Phase | Intervention | LOT | Menopausal status | mPFS time, months | mOS time, months |
|---|---|---|---|---|---|---|---|
| NCT00721409 | PALOMA-1 | II | Let ± Pal | 1st | Post | 20.2 vs. 10.2 | 37.5 vs. 34.5 |
| NCT01740427 | PALOMA-2 | III | Let ± Pal | 1st | Post | 24.8 vs. 14.5 | 53.9 vs. 51.2 |
| NCT01942135 | PALOMA-3 | III | Ful ± Pal | 1st + 2nd + later | Pre/post | 9.2 vs. 3.8 | 34.9 vs. 28.0 |
| NCT02297438 | PALOMA-4 | III | Let ± Pal | 1st (Asian) | Post | 21.5 vs. 13.9 | 51.7 vs. 51.5 |
| NCT01958021 | MONALEESA-2 | III | Let ± Ribo | 1st | Post | 25.3 vs. 16.0 | 63.9 vs. 51.4 |
| NCT02422615 | MONALEESA-3 | III | Ful ± Ribo | 1st + 2nd | Post | 20.5 vs. 12.8 | 53.7 vs. 41.5 |
| NCT02278120 | MONALEESA-7 | III | TAM/NSAI ± Ribo | 1st + 2nd | Pre | 23.8 vs. 13.0 | NR vs. 40.9 |
| NCT02102490 | MONARCH-1 | II | Abema | 2nd | Pre/post | 6.0 | 22.32 |
| NCT02107703 | MONARCH-2 | III | Ful ± Abema | 1st + 2nd | Pre/post | 16.4 vs. 9.3 | 46.7 vs. 37.3 |
| NCT02246621 | MONARCH-3 | III | NSAI ± Abema | 1st | Post | 28.18 vs. 14.76 | - |
| NCT02763566 | MONARCH plus | III | Cohort A: NSAI ± Abema; cohort B: Ful ± Abema | ≥1st (Chinese) | Post | A: NR vs. 14.73; B: 11.47 vs. 5.59 | - |
| NCT03927456 | DAWNA-1 | III | Ful ± Dal | 2nd | Pre/post | 15.7 vs. 7.2 | - |
NCT, National ClinicalTrials.gov identifier; LOT, line of therapy; mPFS, median progression-free survival; mOS, median overall survival; Pal, palbociclib; Ribo, ribociclib; Abema, abemaciclib; Let, letrozole; NSAI, non-steroidal aromatase inhibitor; Ful, fulvestrant; TAM, tamoxifen; Dal, dalpiciclib; Pre, premenopausal; Post, postmenopausal; NR, not reached.