Table 1.
Phase II/III clinical studies with CDK4/6 inhibitors in breast cancer
| Clinical trial | Trial setting | Primary endpoint | Combination | N | Phase |
|---|---|---|---|---|---|
| Abemaciclib | |||||
| neoMONARCH29 | Neoadjuvant | Biomarker | Anastrozole | 220 | II |
| MONARCH-130 | Metastatic | Response | Single agent | 128 | II |
| MONARCH-231 | Metastatic | PFS | Fulvestrant | 630 | III |
| MONARCH-332 | Metastatic | PFS | Nonsteroidal AI | 450 | III |
| NCT0230802033 | Brain metastasis | Response | Single agent | 120 | II |
| Ribociclib | |||||
| MONALEESA-134 | Neoadjuvant | Pharmacodynamic | Letrozole | 120 | II |
| MONALEESA-235 | Metastatic | PFS | Letrozole | 650 | III |
| MONALEESA-336 | Metastatic | PFS | Fulvestrant | 660 | III |
| MONALEESA-737 | Metastatic (premenopausal) | PFS | Tamoxifen Non-steroidal AI | 660 | III |
| Palbociclib | |||||
| PALOMA-1/TRIO-1819 | Metastatic | PFS | Letrozole | 165 | II |
| PALOMA-238 | Metastatic | PFS | Letrozole | 450 | III |
| PALOMA-321 | Metastatic | PFS | Fulvestrant | 417 | III |
| PALOMA-427 | Metastatic | PFS | Letrozole | 330 | III |
| PEARL39 | Metastatic | PFS | Exemestane vs capecitabine | 348 | III |
| PENELOPE-B23 | High risk adjuvant | iDFS | Antihormonal | 800 | III |
| PALLET25 | Neoadjuvant | Biomarker cCR | Letrozole | 306 | II |
| PARSIFAL28 | Metastatic | PFS | Letrozol or Fulvestrant | 304 | III |
| FLIPPER40 | Metastatic | PFS | Letrozol or Fulvestrant | 190 | II |
| PALLAS24 | Adjuvant | iDFS | Antihormonal | 4,600 | III |
| NeoPAL26 | Neoadjuvant | RCB | Letrozole vs FeC-3 | 306 | II |
Abbreviations: AI, aromatase inhibitor; CDK, cyclin D-cyclin-dependent kinase; cCR, clinical complete response, FEC, fluorouracil, epirubicin, cyclophosphamide; iDFS, invasive disease-free interval, N, number of patients; PFS, progression-free survival, RCB, residual cancer burden.