Table 1 Summary of clinical trials evaluating CDK4/6 inhibitors in hormone receptor-positive and HER2-negative metastatic breast cancer.
From: Recent progress of CDK4/6 inhibitors’ current practice in breast cancer
Trial | Phase | N | Treatments | Primary endpoint Results |
|---|---|---|---|---|
PALOMA-2 (NCT01740427) | III | 666 | Letrozole+Palbociclib vs Placebo | PFS 24.8 vs 14.5 months (HR = 0.58, 95% CI: 0.46–0.72) |
MONALEESA-2 (NCT01958021) | III | 668 | Letrozole+Ribociclib vs Placebo | PFS 25.3 vs 16.0 months (HR = 0.568, 95% CI: 0.457–0.704) |
MONARCH-3 (NCT02246621) | III | 493 | NSAI+Abemaciclib vs Placebo | PFS 28.18 vs 14.76 months (HR = 0.540, 95% CI: 0.418–0.698) |
MONALEESA-7 (NCT02278120) | III | 672 | NSAI/Tamoxifen+Ribociclib+goserelin vs Placebo | PFS 23.8 vs 13.0 months (HR = 0.55, 95% CI: 0.44–0.69) |
DAWNA-2 (NCT03966898) | III | 456 | NSAI+Dalpiciclib vs Placebo | PFS 30.6 vs 18.2 months (HR = 0.51, 95% CI: 0.38–0.69) |
MONALEESA-3 (NCT02422615) | III | 726 | Fulvestrant+Ribociclib vs Placebo | PFS in patients receiving first-line treatment 33.6 vs 19.2 months (HR = 0.55, 95% CI: 0.42–0.72) |
FLIPPER (NCT02690480) | II | 189 | Fulvestrant+Palbociclib vs Placebo | mPFS 31.8 vs 22.0 months (HR = 0.55, 95% CI: 0.34–0.78) |
PARSIFAL (NCT02491983) | II | 486 | Palbociclib+Fulvestrant vs Letrozole | PFS 27.9 vs 32.8 months (HR = 1.13, 95% CI: 0.89–1.45) |
MONARCH-2 (NCT02107703) | III | 669 | Fulvestrant+Abemaciclib vs Placebo | PFS 16.4 vs 9.3 months (HR = 0.553, 95% CI: 0.449–0.681) |
MONARCH plus (NCT02763566) | III | 207 | NSAI+Abemaciclib+ vs Placebo | PFS NR vs 14.7 months (HR = 0.499, 95% CI: 0.346–0.719) |
104 | Fulvestrant+Abemaciclib vs Placebo | PFS 11.5 vs 5.6 months (HR = 0.376, 95% CI: 0.240–0.588) | ||
PALOMA-3 (NCT01942135) | III | 105 | Fulvestrant+Palbociclib vs Placebo | PFS in premenopausal women age ≤50 years 9.5 vs 5.6 months (HR = 0.50, 95% CI: 0.29–0.87) |
LEONARDA-1 (NCT05054751) | III | 275 | Fulvestrant+Lerociclib vs Placebo | PFS 11.07 vs 5.49 months (HR = 0.458, 95% CI: 0.317–0.661) |
MAINTAIN (NCT02632045) | II | 119 | Fulvestrant/Exemestane+Ribociclib vs Placebo | PFS 5.29 vs 2.76 months (HR = 0.57, 95% CI: 0.39–0.85) |
BioPER (NCT03184090) | II | 33 | Palbociclib+ET of physician’s choice | CBR 34.4% (95% CI: 18.6–53.2); 13.0% of tumors (95% CI: 5.2–27.5) showed loss of Rb protein expression |
RIGHT (NCT03839823) | II | 222 | Ribociclib+goserelin+NSAI vs chemotherapy | PFS 24.0 vs 12.3 months (HR = 0.54, 95% CI: 0.36–0.79) |
