Table 1.
Ongoing combination trials (recruiting or not yet recruiting) with CDK4/6 inhibitors in breast cancer (www.clinicaltrials.gov, updated on 3/7/18).
| Drug | Phase | Arms | Planned n |
Trial status | NCT | Remarks |
|---|---|---|---|---|---|---|
| PALBOCICLIB | ||||||
| HR+/HER2− | ||||||
| CPI | ||||||
| Pembrolizumab | II | Palbociclib + letrozole + pembrolizumab | 22 | Recruiting | NCT02778685 | |
| Pan-PI3K inhibitor | ||||||
| Copanlisib | II | Palbociclib + fulvestrant ± copanlisib | 178 | Not yet recruiting | NCT03377101 | |
| Copanlisib | I/II | Palbociclib + letrozole + copanlisib | 102 | Recruiting | NCT03128619 | |
| α-specific PI3K inh | ||||||
| GDC-0077 | I | Palbociclib + letrozole + GDC-0077 | 156 | Recruiting | NCT03006172 | |
| mTOR inhibitors | ||||||
| Everolimus | I/II | Palbociclib + everolimus + exemestane | 32 | Recruiting | NCT02871791 | |
| Gedatolisib | Ib | Palbociclib + gedatolisib + letrozole or fulvestrant | 120 | Recruiting | NCT02684032 | |
| SERD/SERM | ||||||
| GDC-9545 | I | Palbociclib + GDC-9545 + LHRH | 130 | Recruiting | NCT03332797 | |
| SAR439859 | I/II | SAR439859 ± palbociclib | 156 | Recruiting | NCT03284957 | |
| Bazedoxifene | I/II | Palbociclib + Bazedoxifene | 37 | Recruiting | NCT02448771 | |
| FGFR inhibitor | ||||||
| Erdafitinib | I | Palbociclib + fulvestrant + erdafitinib | 32 | Recruiting | NCT03238196 | ER+/HER2-FGFR amplified |
| HER2+ | ||||||
| Trastuzumab + pertuzumab | I/II | Anastrozole + palbociclib + trastuzumab + pertuzumab | 36 | Recruiting | NCT03304080 | ER+ only |
| Trastuzumab | II | Letrozole + palbociclib + trastuzumab | 48 | Recruiting | NCT02907918 | Neoadjuvant ER+ only |
| Trastuzumab | II | Palbociclib + trastuzumab ± letrozole | 138 | Recruiting | NCT02448420 | |
| Anti-HER2 therapy | III | Anti-HER2 Therapy + ET ± palbociclib | 496 | Recruiting | NCT02947685 | |
| TDM1 | Ib | Palbociclib + TDM1 | 17 | Recruiting | NCT01976169 | |
| Tucatinib | Ib/II | Palbociclib + letrozole + tucatinib | 40 | Not yet recruiting | NCT03054363 | ER+ only |
| AR+ | ||||||
| AR antagonists | ||||||
| Bicalutamide | I/II | Palbociclib + bicalutamide | 51 | Recruiting | NCT02605486 | |
| RIBOCICLIB | ||||||
| HR+ HER2− | ||||||
| CPI | ||||||
| PDR001 | I | Ribociclib + PDR001 + fulvestrant | 60 | Recruiting | NCT03294694 | |
| SERD | ||||||
| LSZ102 | I/Ib | LSZ102 | 312 | Recruiting | NCT02734615 | |
| LSZ102 + ribociclib | ||||||
| LSZ102 + alpelisib | ||||||
| α-specific PI3K inh | ||||||
| Alpelisib | Ib/II | Ribociclib + alpelisib + letrozole | 253 | Recruiting | NCT01872260 | |
| mTOR inhibitors | ||||||
| Everolimus | I/II | Ribociclib + everolimus + exemestane | 51 | Recruiting | NCT02732119 | |
| HER2− | ||||||
| Capecitabine | I | Ribociclib + capecitabine | 52 | Recruiting | NCT02754011 | |
| Any HR/HER2 | ||||||
| Paclitaxel | I | Riboclicib + paclitaxel | 28 | Recruiting | NCT02599363 | |
| HER2+ | ||||||
| Trastuzumab or TDM1 | Ib/II | Ribociclib + TDM1 | 86 | Recruiting | NCT02657343 | |
| Ribociclib + trastuzumab ± fulvestrant | ||||||
| AR+ | ||||||
| AR antagonists | ||||||
| Bicalutamide | I/II | Ribociclib + bicalutamide | 58 | Recruiting | NCT03090165 | |
| ABEMACICLIB | ||||||
| HR+ HER− | ||||||
| CPI | ||||||
| LY3300054 | I | Abemaciclib + LY3300054 | 115 | Recruiting | NCT02791334 | |
| mTOR and PI3K inhibitos | ||||||
| Everolimus | I | Abemaciclib + everolimus + exemestane | 123 | Recruiting | NCT02057133 | |
| LY3023414 | Abemaciclib + LY3023414 + fulvestrant | |||||
| LY3023414 | I | Abemaciclib + LY3023414 + Letrozole | 130 | Recruiting | NCT01655225 | |
| IGF antibody | ||||||
| Xentuzumab | I | Abemaciclib + xentuzumab ± ET | 88 | Recruiting | NCT03099174 | |
| HER2+ | ||||||
| Trastuzumab | I | Abemaciclib + trastuzumab | 123 | Recruiting | NCT02057133 | |
| Trastuzumab | II | Abemaciclib + trastuzumab ± fulvestrant vs chemotherapy | 225 | Not yet recruiting | NCT02675231 |
Legend: ET – endocrine therapy; IGF - insulin like growth factor; HR – hormone receptor; HER2 – human epidermal receptor2; AR – androgen receptor; TDM1 – ado trastuzumab; FGFR – fibroblast growth factor receptor; SERD – selective estrogen receptor degrader; SERM – selective estrogen receptor modulator; mTOR – mammalian target of rapamycin; CPI – checkpoint inhibitor; PI3K - Phosphatidylinositol-3 kinase.