Table 1 Completed phase II–III clinical trials investigating CDK4/6 inhibitors in hormone receptor-positive metastatic breast cancer (mBC)
From: Are all cyclin-dependent kinases 4/6 inhibitors created equal?
Trial | Study design | Randomized | Phase | Sample size | Population | Experimental arm | Control arm | PFS (months) | OS (months) |
|---|---|---|---|---|---|---|---|---|---|
Paloma-1 | Open label | Yes 1:1 | 2 | 165 | AI sensitive Treatment naive for mBC Postmenopausal | Palbociclib plus Letrozole | Letrozole | 20.2 vs 10.2 HR 0.48 | 37.5 vs 34.5 HR 0.89 (NS) |
Paloma-2 | Placebo control | Yes 2:1 | 3 | 666 | AI sensitive Treatment naive for mBC Postmenopausal | Palbociclib plus Letrozole | Letrozole plus placebo | 24.8 vs 14.5 HR 0.58 | NA |
Paloma-3 | Placebo control | Yes 2:1 | 3 | 521 | Endocrine resistant Pre/peri and postmenopausal | Palbociclib plus Fulvestrant | Fulvestrant plus placebo | 9.5 vs 4.6 HR 0.46 | 34.9 vs 28.0 HR 0.81 |
Monarch-1 | Open label | No | 2 | 184 | AI resistant CT treated mBC Postmenopausal | Abemaciclib | /// | 6.0 | 22.3 |
Monarch-2 | Placebo control | Yes 2:1 | 3 | 669 | AI resistant CT naive for mBC Pre/peri and Postmenopausal | Abemaciclib plus Fulvestrant | Fulvestrant plus placebo | 16.4 vs 9.3 HR 0.55 | NA |
Monarch-3 | Placebo control | Yes 2:1 | 3 | 493 | Endocrine sensitive Postmenopausal | Abemaciclib plus Anastrozole/Letrozole | Anastrozole/Letrozole plus placebo | 28.1 vs 14.7 HR 0.54 | NA |
Monaleesa-2 | Placebo control | Yes 1:1 | 3 | 668 | Endocrine sensitive Treatment naive for mBC Postmenopausal | Ribociclib plus Letrozole | Letrozole plus placebo | 25.3 vs 16.0 HR 0.56 | NA |
Monaleesa-3 | Placebo control | Yes 2:1 | 3 | 725 | Endocrine sensitive and endocrine resistant mBC Postmenopausal | Ribociclib plus Fulvestrant | Fulvestrant plus placebo | 20.5 vs 12.8 HR 0.59 | NA |
Monaleesa-7 | Placebo control | Yes 2:1 | 3 | 672 | Endocrine sensitive Pre/perimenopausal | Ribociclib plus Anastrozole/Letrozole plus LH–RH analog | Anastrozole/Letrozole plus LH–RH analog plus placebo | 23.8 vs 13.0 HR 0.55 | NR vs 40.9 HR 0.71 |
