Profile of buparlisib and its potential in the treatment of breast cancer: evidence to date

Figures & data

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
HR+ HER2+/−	Metastatic BC	NCT01248494	Ib	C	72	BEZ235 + letrozole BKM120 continuous + letrozole BMK102 intermittent + letrozole
HR+/HR− HER2+	Neoadjuvant treatment in EBC	NCT01816594 (NeoPHOEBE)	II	C	50	BKM120/placebo + trastuzumab + paclitaxel
HR+/HR− HER2−	Locally advanced/metastatic BC	NCT01572727 BELLE-4	II/III	C	416	BMK120/placebo + paclitaxel
HR+/− HER2+/−	Metastatic BC	NCT01300962	I	ANR	47	BKM120 + capecitabine BYL719 + capecitabine BKM120 + capecitabine + trastuzumab BKM120 + capecitabine + lapatinib
All subtypes	Metastatic BC with brain metastases	NCT02000882	II	R	40	BKM120 + capecitabine ± trastuzumab
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
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
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.