Table 2 Currently registered clinical studies with CDK4/6 inhibitors in breast cancer
From: Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers
Compound | Setting | Trial primary endpoint | Combination | N | Phase | ClinicalTrials.gov identifier |
|---|---|---|---|---|---|---|
Palbociclib (PD-0332991) | First-line metastatic | PFS | Letrozole | 450 | III | NCT01740427 (PALOMA-2) |
| Â | Metastatic | PFS | Fulvestrant | 417 | III | NCT01942135 (PALOMA-3) |
| Â | High-risk adjuvant | iDFI | Anti-hormonal | 800 | III | NCT01864746 (PENELOPE-B) |
| Â | Neo-adjuvant | pCR | Anastrozole | 29 | II | NCT01723774 |
| Â | Pre-operative | ORR | Letrozole | 45 | II | NCT01709370 |
| Â | Metastatic | MTD | Paclitaxel | 20 | I | NCT01320592 |
| Â | Neo-adjuvant | Biomarker cCR | Letrozole | 306 | II | NCT02296801 (PALLET) |
| Â | Metastatic | PFS | Exemestane versus capecitabine | 348 | III | NCT02028507 (PEARL) |
| Â | Adjuvant | Treatment discontinuation | Letrozole | 160 | II | NCT02028507 |
| Â | Metastatic | Dose/toxicity | TDM-1 | 17 | Ib | NCT01976169 |
| Â | Neoadjuvant | RCB | Letrozole versus FEC-3 | 132 | II | NCT02400569 (NeoPAL) |
| Â | Adjuvant | iDFS | SAT | 4600 | III | NCT02513394 (PALLAS) |
Ribociclib (LEE011) | First-line metastatic | PFS | Letrozole | 450 | III | NCT01958021 |
| Â | Pre-surgical | PD | Letrozole | 120 | II | NCT01919229 (MONALEESA-1) |
| Â | Metastatic | DLT, PFS | BYL719, letrozole | 300 | I/II | NCT01872260 |
| Â | Metastatic | DLT, PFS | Exemestane, everolimus | 185 | Ib/II | NCT01857193 |
| Â | Metastatic | PFS | Letrozole | 650 | III | NCT01958021 (MONALEESA-2) |
| Â | Metastatic | DLT | Letrozole, buparlisib | 13 | I | NCT02154776 |
| Â | Metastatic (pre-menopausal) | PFS | Tamoxifen, NSAI | 660 | III | NCT2278120 (MONALEESA-7) |
| Â | Metastatic | DLT/PFS | BYL719a or BKM120 | 216 | I/II | NCT01872260 |
| Â | Metastatic | PFS | Fulvestrant | 660 | III | NCT02422615 (MONALEESA-3) |
Abemaciclib (LY2835219) | Neoadjuvant | Biomarker | Anastrozole | 220 | II | NCT02441946 (NeoMONARCH) |
| Â | Brain metastasis | Response | Single agent | 120 | II | NCT02308020 |
| Â | Metastatic | PFS | NSAI | 450 | III | NCT02246621 (MONARCH-3) |
| Â | Metastatic | Response | Single agent | 128 | II | NCT021024490 (MONARCH-1) |
| Â | Metastatic | PFS | Fulvestrant | 630 | III | NCT02107703 (MONARCH-2) |
| Â | Metastatic | PFS | NSAI, tamoxifen, exemestane, everolimus, trastuzumab | 102 | I | NCT02057133 |