Table 1.
Ongoing trials testing the combination of buparlisib with various anti-cancer drugs
| Subtype | Setting | #NCT | Phase | Status | Number of patients | Treatment |
|---|---|---|---|---|---|---|
| HR+ HER2− |
Locally advanced/metastatic BC previously treated with AI and mTOR inhibitors | NCT01633060 (BELLE-3) | III | ANR | 432 | BMK120/placebo + fulvestrant |
| Locally advanced/metastatic BC refractory to AI | NCT01610284 | III | ANR | 1149 | BMK120/placebo + fulvestrant | |
| Locally advanced/metastatic BC with prior hormonal therapy |
NCT02404844 PIKTAM |
II | ANR | 48 | BMK120 + tamoxifen | |
| Neoadjuvant treatment of EBC | NCT01923168 | II | C | 340 | BYL719/placebo + letrozole BMK120/placebo + letrozole |
|
| Metastatic BC | NCT02088684 | Ib/II | ANR | 70 | LEE011 + BKM120 + fulvestrant LEE011 + BYL719 + fulvestrant LEE011 + fulvestrant |
|
| Locally advanced/metastatic BC | NCT02058381 (B-YOND) | Ib | ANR | 40 | BYL719 or BKM120 + tamoxifen + goserelin acetate | |
| Metastatic BC | NCT01339442 | I | C | 31 | BMK120 continuous or intermittent + fulvestrant | |
|
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| HR+ HER2+/− |
Metastatic BC | NCT01248494 | Ib | C | 72 | BEZ235 + letrozole BKM120 continuous + letrozole BMK102 intermittent + letrozole |
|
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| HR+/HR− HER2+ |
Neoadjuvant treatment in EBC | NCT01816594 (NeoPHOEBE) | II | C | 50 | BKM120/placebo + trastuzumab + paclitaxel |
|
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| HR+/HR− HER2− |
Locally advanced/metastatic BC |
NCT01572727 BELLE-4 |
II/III | C | 416 | BMK120/placebo + paclitaxel |
|
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| HR+/− HER2+/− |
Metastatic BC | NCT01300962 | I | ANR | 47 | BKM120 + capecitabine BYL719 + capecitabine BKM120 + capecitabine + trastuzumab BKM120 + capecitabine + lapatinib |
|
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| All subtypes | Metastatic BC with brain metastases | NCT02000882 | II | R | 40 | BKM120 + capecitabine ± trastuzumab |
|
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| TNBC | Metastatic BC | NCT01629615 | II | C | 50 | BMK120 |
| TNBC | Metastatic BC | NCT01790932 | II | ANR | 110 | BMK120 |
| TNBC | Metastatic BC | NCT01623349 | I | ANR | 118 | BYL719 + olaparib |
| Ovarian cancer | BMK102 + olaparib | |||||
|
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| Solid tumors | Advanced solid tumors | NCT01363232 | Ib | ANR | 89 | BKM120 + MEK162 |
| Solid tumors | Advanced solid tumors | NCT01155453 | Ib | C | 113 | BKM120 + GSK1120212 |
| Solid tumors | Advanced solid tumors | NCT01285466 | Ib | C | 110 | BEZ235 + paclitaxel |
| HER2+ BC | BKM120 + paclitaxel BEZ235 + paclitaxel + trastuzumab BKM120 + paclitaxel + trastuzumab |
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| Solid tumors | Advanced solid tumors | NCT01576666 | Ib | C | 120 | LDE225 + BKM120 |
Abbreviations: AI, aromatase inhibitors; ANR, active, not recruiting; BC, breast cancer; C, completed; EBC, early breast cancer; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mTOR, mammalian target of rapamycin; R, recruiting; TNBC, triple-negative breast cancer.