Copyright
©The Author(s) 2018.
World J Clin Oncol. Dec 20, 2018; 9(8): 172-179
Published online Dec 20, 2018. doi: 10.5306/wjco.v9.i8.172
Published online Dec 20, 2018. doi: 10.5306/wjco.v9.i8.172
Table 1 Clinical trials inhibiting PI3K-mTOR pathway in HR+, HER2- breast cancer patients
| Clinical trial identifier | Phase | Year | Administered drug(s) (target) | Primary endpoint | Target/s of the PI3K-mTOR pathway |
| NCT00699491 | 1/2 | 18.06.2008 | Cixutumumab + temsirolimus | ORR | mTOR |
| Bolero 2; NCT00863655 [16] | 3 | 18.03.2009 | Everolimus + exemestane or placebo + exemestane | PFS | mTOR |
| NCT00876395 | 3 | 06.04.2009 | Everolimus + placebo | PFS | mTOR |
| NCT01219699 | 1 | 13.10.2010 | BYL719 + fulvestrant | MTD | PI3Kα |
| NCT01283789 | 2 | 26.01.2011 | Everolimus + lapatinib | ORR | mTOR |
| TAMRAD; NCT01298713 [14] | 2 | 18.02.2011 | Everolimus + tamoxifen | CBR | mTOR |
| BELLE-2; NCT01610284 | 3 | 04.06.2012 | Fulvestrant ± BKM120 (AIs refractory pts) | PFS | PI3K |
| BELLE-3; NCT01633060 | 3 | 04.06.2012 | Fulvestrant ± BKM120 (Pts previously on mTOR inhibitors) | PFS | PI3K |
| NCT01627067 | 2 | 25.06.2012 | Everolimus + exemestane + metformin | PFS | mTOR |
| NCT01674140 | 3 | 28.08.2012 | Everolimus + standard adjuvant endocrine therapy (tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane) | Invasive DFS | mTOR |
| Bolero 4; NCT01698918 | 2 | 03.10.2012 | Everolimus + letrozole | PFS | mTOR |
| NCT01776008 | 2 | 25.01.2013 | everolimus + exemestane; MK2206 + anastrozole ± goserelin acetate | CRR | Akt |
| NCT01783444; Bolero-6 | 2 | 05.02.2013 | Everolimus or capecitabine or everolimus + exemestane | PFS | mTOR |
| NCT01791478 | 1 | 15.02.2013 | BYL719 + letrozole | DLT | PI3Kα |
| NCT01805271 | 3 | 06.03.2013 | Everolimus + placebo | DFS | mTOR |
| CLEE011X2107; NCT01872260 | 1b/2 | 07.06.2013 | Letrozole + ribociclib + alpesilib | DLT | PI3K |
| INPRES; NCT01948960 | 4 | 24.09.2013 | Everolimus | AUC correlation with age and/or obesity | mTOR |
| NCT01992952 | 1/2 | 25.11.2013 | Fulvestrant ± AZD5363 or placebo | MTD | Akt |
| PEARL; NCT02028364 | 2 | 07.01.2014 | Everolimus + exemestane | PFS and response by PET | mTOR |
| NCT02035813 | 2 | 14.01.2014 | Everolimus + eribulin | PFS | mTOR |
| NCT02049957 | 1b/2 | 30.01.2014 | MLN0128 + exemestane vs MLN0128 + fulvestrant | Participant with AE and Clinical Benefit Rate | mTORC1/2 |
| NCT02057133 | 1b | 06.02.2014 | LY2835219 + exemestane + everolimus vs exemestane + everolimus vs LY2835219 + trastuzumab vs LY2835219 + anastrazole vs LY2835219 + tamoxifen vs LY2835219 + letrozole vs LY3023414 + LY2835219 + fulvestrant | Safety | mTOR |
| NCT02058381 | 1b | 10.02.2014 | BYL719 + BKM120 | MTD | PI3Kα + PI3K |
| NCT02077933 | 1 | 04.03.2014 | Alpelisib + everolimus + exemestane | DLT and MTD | PI3K + mTOR |
| NCT02123823 | 1b | 28.04.2014 | BI 836845 + everolimus + exemestane | PFS, MTD and DLT | mTOR |
| NCT02216786 | 2 | 15.08.2014 | Everolimus + fulvestrant vs AZD2014 + fulvestrant | PFS | mTOR + mTORC1/2 |
| NCT02236572 | 2 | 10.09.2014 | Everolimus + aromatase inhibitor | Preoperative Endocrine Prognostic Index | mTOR |
| NCT02269670 | 2 | 21.10.2014 | Everolimus + endocrine therapy (anastrozole, letrozole, tamoxifen citrate, fulvestrant or megestrol acetate) | PFS and ORR | mTOR |
| NCT02285179 | 1/2 | 16.11.2014 | Taselisib + tamoxifen | MTD | PI3K |
| NCT02291913 | 2 | 17.11.2014 | Everolimus + anti-estrogen therapy (exemestane, tamoxifen, fulvestrant, anastrozole, letrozole, toremifine ) | PFS | mTOR |
| Sandpiper NCT02340221 | 3 | 16.01.2015 | Taselisib + fulvestrant vs placebo + fulvestrant | PFS | PI3K |
| FEVEX; NCT02404051 | 3 | 31.03.2015 | Everolimus + exemestane vs everolimus + exemestane (at progression fulvestrant) | PFS | mTOR |
| NCT02404844 | 2 | 01.04.2015 | BKM120 + tamoxifen | PFS | PI3K |
| NCT02379247 | 04.05.2015 | BYL719 + Nab-paclitaxel | DLT , ORR for Phase II | PI3Kα | |
| SOLAR-1; NCT02437318 | 3 | 07.05.2015 | Fulvestrant ± alpelisib (AIs refractory pts) | PFS | PI3K |
| NCT02506556 | 2 | 23.07.2015 | BYl719 | ORR | PI3Kα |
| NCT02511639 | 3 | 30.07.2015 | Everolimus + aromatase inhibitors | PFS | mTOR |
| NCT02520063 | 1/2 | 11.08.2015 | Letrozole + everolimus + TRC105 | MTD | mTOR |
| NCT02619669 | 1 | 02.12.2015 | Sapanisertib + letrozole | TAE | mTORC1/2 |
| TRINITI-1; NCT02732119 | 1/2 | 08.04.2016 | Everolimus + ribociclib + exemestane | MTD | mTOR |
| NCT02742051 | 2 | 18.04.2016 | Everolimus + letrozole vs neoadjuvant+ fluorouracil, epirubicin + cyclophosphamide (FEC) | ORR | mTOR |
| NCT02871791 | 2 | 18.08.2016 | Everolimus + exemestane | DLT | mTOR |
| NCT02988986 | 2 | 12.12.2016 | Sapanisertib + tamoxifen | Change in Ki67 expression | mTORC1/2 |
| CLEVER; NCT03032406 | 2 | 26.01.2017 | Everolimus ± hydroxychloroquine | AE | mTOR |
| NCT03056755 | 2 | 17.02.2017 | Alpelisib + fulvestrant + letrozole (AIs and CDK4/6 refractory pts) | DFS | PI3K |
| NCT03128619 | 1/2 | 25.04.2017 | Copanlisib + letrozole + palbociclib | MTD | PI3K |
| EVEREXES; NCT03176238 | 3 | 05.06.2017 | Everolimus + exemestane | AE | mTOR |
| NCT03207529 | 1 | 02.07.2017 | BYL719 + enzalutamide | MTD | PI3Kα |
| NCT03377101 | 2 | 19.12.2017 | Fulvestrant + palbociclib ± copanlisib | DLT | PI3K |
- Citation: Sobhani N, Generali D, Zanconati F, Bortul M, Scaggiante B. Current status of PI3K-mTOR inhibition in hormone-receptor positive, HER2-negative breast cancer. World J Clin Oncol 2018; 9(8): 172-179
- URL: https://www.wjgnet.com/2218-4333/full/v9/i8/172.htm
- DOI: https://dx.doi.org/10.5306/wjco.v9.i8.172