Table 3.
This table summarizes the trials investigating the use of cyclin-dependent kinase inhibitors in the adjuvant setting.
Trial | Year | Status | Patient Population | Intervention | Control Arm | Primary Outcome |
---|---|---|---|---|---|---|
PENELOPE-B (NCT01864746) | 2013–2020 | Completed | HR+, HER2− EBC | PAL (125 mg once daily for 13 cycles) + ≥5 years ET | ET + placebo | 42.8-month iDFS: no difference; (HR = 0.93, 95% CI: 0.74–1.17); two-sided weighted log-rank test (Cui, Hung, and Wang) p = 0.525 |
PALLAS (NCT02513394) | 2015–2020 | Completed | HR+, HER2− EBC | PAL (125 mg orally once daily for 2 years) + ≥5 years ET | ET alone | 31-month iDFS: 8.8% PAL + ET vs. 9.1% ET, iDFS at 4 years: 84.2% vs. 84.5% (HR = 0.96, 95% CI: 0.81–1.14, p = 0.65) |
MonarchE (NCT03155997) | 2017–2020 | Completed | HR+, HER2− EBC | Abemaciclib (150 mg twice daily for 2 years) + ET ≥5 years | ET alone | 3-year iDFS improved by 5.4% in the abemaciclib group (HR = 0.70, 95% CI: 0.59–0.82) |
MonarchE (NCT03155997) | 2018–2026 | Active | HR+, HER2− EBC | RIBO (400 mg/day 3 weeks on, 1 week off for 3 years) + ET ≥5 years | ET alone | 34-month iDFS improved by 3.3% in the RIB + ET group; iDFS (HR, 0.748; 95% CI, 0.618–0.906; p = 0.0014); 3-year iDFS rates: 90.4% vs. 87.1% |