Table 1.
Summary of ongoing clinical trials involving PI3K/AKT/mTOR in ER+ breast cancer
| Target | Compound | NCT number | Population |
|---|---|---|---|
| PI3K | AZD5363, Paclitaxel | NCT01625286 | ER+ MBC |
| BKM120 or BYL719 and Capecitabine | NCT01300962 | ||
| BYL719, Letrozole or Exemestane | NCT01870505 | ||
| BYL719, Letrozole | NCT01791478 | ||
| GDC-0032, Letrozole or Fulvestrant | NCT01296555 | ||
| Taselisib, Fulvestrant | NCT02340221 | ||
| Alpelisib, Fulvestrant | NCT02437318 | ||
| Alpelisib, hormone therapy | NCT03056755 | PIK3CA-mutant | |
| BYL719, Fulvestrant | NCT01219699 | ||
| AZD8186, Docetaxel | NCT03218826 | PTEN or PIK3CB mutant | |
| Taselisib, Enzalutamide | NCT02457910 | Androgen Receptor+ MBC | |
| mTOR | Everolimus to adjuvant hormone therapy | NCT01805271 | Adjuvant ER+ |
| Everolimus, standard hormone therapy | NCT01805271 | ||
| TAK-228 then Letrozole | NCT02619669 | ||
| TAK-228, Tamoxifen | NCT02988986 | ER+ MBC | |
| Everolimus, Letrozole | NCT01698918 | ||
| AZD2014, Fulvestrant | NCT02216786 | ||
| Everolimus, Exemestane | NCT01783444 | ||
| Everolimus, Tamoxifen | NCT01298713 | ||
| mTOR, IGF1R | Ridaforolimus, Dalotuzumab, Exemestane | NCT01605396 | ER+ MBC |
| AKT | AZD5363 | NCT03310541 | AKT-mutant |
| AZD5363, Fulvestrant | NCT01992952 | ER+ MBC | |
| AZD5363 | NCT01226316 | MBC | |
| MSC2363318A, with Trastuzumab or Tamoxifen | NCT01971515 | ||
| AKT, PD-L1, MEK, VEGF | Ipatasertib, Atezolizumab, Cobimetinib, Bevacizumab | NCT03395899 | Neoadjuvant ER+ |
| PI3K, mTOR, CDK | Ribociclib, Everolimus, Exemestane | NCT01857193 | ER+ MBC |
| Gedatolisib, Fulvestrant, Palbociclib, Goserelin | NCT02626507 | ||
| PI3K, CDK | Ribociclib, Fulvestrant and BYL719 or BKM120 | NCT02088684 | |
| Ribociclib, Letrozole, BYL719 | NCT01872260 | ||
| Ribociclib, Tamoxifen, Letrozole, Anastrozole, Goserelin | NCT02278120 | ||
| mTOR, CDK | Ribociclib, Everolimus, Exemestane | NCT02732119 | |
| Hormone therapy, hormone therapy with Everolimus, or hormone therapy with CDK4/6 inhibition | NCT02753686 |
MBC, metastatic breast cancer; IGF1R, Insulin Growth Factor 1 Receptor; PD-L1, programmed death-ligand 1; MEK, Mitogen-activated protein kinase kinase. Table updated from clinicaltrials.gov on March 11, 2018.